RARITAN, N.J., Aug. 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw) plus Lazcluze™ (lazertinib) for the first-line treatment...

CAMBRIDGE, Mass., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved...

16 August 2024 -- AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known...

Basel, August 8, 2024 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with...

WILMINGTON, Del. & WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 14, 2024-- Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Niktimvo...

FOSTER CITY, Calif.--(BUSINESS WIRE) August 14, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary...

Zug, Switzerland – August 13, 2024 – Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo...

COPENHAGEN, Denmark, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of...

Basel, August 12, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled...

BRIDGEWATER, N.J.--(BUSINESS WIRE) August 7, 2024 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Crexont (carbidopa...

SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to...

CRANFORD, N.J., Aug. 8, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius", "Citius Pharma"), announced today that the U.S. Food and Drug Administration (FDA) has approved Lymphir (denileukin diftitox-cxdl), a novel...

STAMFORD, Conn., August 7, 2024 – Purdue Pharma L.P. (“Purdue”) announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai (nalmefene injection) Auto-Injector...

BOSTON, Mass. – August 6, 2024 – Servier today announced that the U.S. Food and Drug Administration (FDA) has approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the...

On August 6, 2024, the Food and Drug Administration approved vorasidenib (Voranigo, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and...

Philadelphia, PA -- August 01 2024 GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a...

PHILADELPHIA & OXFORD, England--(BUSINESS WIRE) August 01, 2024 -- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced U.S. Food and Drug...

PHILADELPHIA & OXFORD, England--(BUSINESS WIRE) August 01, 2024 -- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy, today announced U.S. Food and Drug...

HORSHAM, Pa., July 30, 2024 – Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and...

BARCELONA, Spain, July 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that the United States Food and Drug Administration (FDA) has...

VANCOUVER, B.C., and Dallas, July 29, 2024 - Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative...

PRINCETON, N.J., July 28, 2024 – Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced that the U.S. Food and Drug Administration...

July 26, 2024 -- Today, the FDA approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to...

SAN RAFAEL, Calif., July 24, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Brineura...

FOSTER CITY, Calif.--(BUSINESS WIRE) July 25, 2024 -- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Livmarli (maralixibat) oral solution for the...

MUMBAI, India and PRINCETON, N.J., July 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or associate companies) today...

On July 22, 2024, the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl...

RALEIGH, NC – July 23, 2024 -- Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the U.S. Food and Drug Administration (FDA) approved Xeomin (incobotulinumtoxinA) as the first and only neurotoxin...

Ahmedabad, India, 19 July 2024 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval for its New Drug Application (NDA) from the United States Food and Drug...

INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli® (eculizumab-aagh) as a...

FLORHAM PARK, N.J., July 18, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today the U.S...

WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S...

July 01, 2024 Tanvex BioPharma, Inc. (TWSE: 6541) announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of Nypozi (TX01) and approved the biologics license application (BLA) on June 28...

South San Francisco, CA -- July 4, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled...

INDIANAPOLIS, July 2, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company's (NYSE: LLY) Alzheimer's treatment for...

Planegg-Martinsried, Germany July 1, 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (“FDA”)...

Basel, July 1, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled...

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R)...

CAMBRIDGE, Mass.--(BUSINESS WIRE) June 28, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug...

CAMBRIDGE, Mass.--(BUSINESS WIRE) June 28, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug...

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre...

CORAL GABLES, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for...

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Wakix® (pitolisant) tablets...

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40...

Amsterdam, the Netherlands June 21, 2024 -- argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug...

PRINCETON, N.J.--(BUSINESS WIRE) June 21, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Krazati® (adagrasib) in combination with cetuximab as a...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2024-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) approval of an expansion to the labeled...

Philadelphia and Phoenix US, 20 June 2024 -- Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Administration (FDA) approval of Sofdra™ (sofpironium) gel...

TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE) May 29, 2024 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has...

NORTH CHICAGO, Ill., June 18, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making...

PARSIPPANY, N.J.--(BUSINESS WIRE) June 17, 2024 --Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that the U.S. Food and Drug Administration...

RAHWAY, N.J.--(BUSINESS WIRE) June 17, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Capvaxive™ (Pneumococcal 21-valent Conjugate...

Barcelona, Spain, June 17, 2024 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest, a Grifols Group company, has received approval from the United...

RAHWAY, N.J.--(BUSINESS WIRE) June 17, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in...

PRINCETON, N.J.--(BUSINESS WIRE) June 13, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro (repotrectinib) for the treatment of adult and pediatric...

On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid...

12 June 2024 – AstraZeneca’s Xigduo XR (dapagliflozin/metformin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. The...

MADISON, N.J.--(BUSINESS WIRE)-- June 13, 2024. LEO Pharma Inc. has today announced approval from the U.S. Food and Drug Administration (FDA) for a new Adbry (tralokinumab-ldrm) 300 mg single-dose autoinjector for adult patients. Adbry, a...

On June 14, 2024, the Food and Drug Administration approved Imfinzi (durvalumab), AstraZeneca UK Limited, with carboplatin plus paclitaxel followed by single-agent Imfinzi for adult patients with primary advanced or recurrent endometrial cancer that...

THOUSAND OAKS, Calif., June 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved Blincyto (blinatumomab) for the treatment of adult and pediatric patients one month or older with...

12 June 2024 – AstraZeneca’s Xigduo XR (dapagliflozin/metformin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. The...

SILVER SPRING, MD. June 7, 2024/FDA Approvals/ -- Today, the U.S. Food and Drug Administration (FDA) approved Aucta Pharmaceuticals Motpoly XR (lacosamide) capsules (100 mg, 150 mg, and 200 mg) for the treatment of primary generalized tonic-clonic...

MALVERN, PA. June 10, 2024 -- Almirall, a global pharmaceutical company dedicated to medical dermatology, announced today that the U.S. Food and Drug Administration (FDA) has approved Almirall’s recent supplemental New Drug Application (sNDA)...

12 June 2024 – AstraZeneca’s Farxiga (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval...

PARIS, FRANCE, 10 June 2024: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis...

PARIS, FRANCE, 10 June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis...

TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of...

Optum RX: April 25, 2024. Today, the FDA approved Amgen’s Otezla (apremilast), for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for...

Philadelphia, PA June 07 2024 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract...

FOSTER CITY, Calif.--(BUSINESS WIRE) June 6, 2024 -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the U.S. Food and Drug...

CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60...

PRINCETON, N.J.--(BUSINESS WIRE) May 30, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted approval for Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric...

May 29, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the U.S. Food...

May 29, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the U.S. Food...

May 28, 2024 -- Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications...

PARSIPPANY, N.J.--(BUSINESS WIRE) April 01, 2024 --Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that Vigpoder™ (vigabatrin) for oral...

Philadelphia, PA May 20 2024 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg subcutaneous route of administration of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific...

PRINCETON, N.J.--(BUSINESS WIRE) May 15, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed...

THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Imdelltra™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small...

DEERFIELD, Ill. - 2024-05-13 -- Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients,...

May 08, 2024 -- On April 5, 2024, the US Food and Drug Administration (FDA) approved Sandoz’s supplemental biologics license application (sBLA) seeking interchangeability to include the 10 mg/0.1 mL, 20mg/0.2 mL, and 80 mg/0.8 mL strengths in...

May 08, 2024 -- On April 5, 2024, the US Food and Drug Administration (FDA) approved Sandoz’s supplemental biologics license application (sBLA) seeking interchangeability to include the 10 mg/0.1 mL, 20mg/0.2 mL, and 80 mg/0.8 mL strengths in...

Paris, May 10, 2024 -- The US Food and Drug Administration (FDA) has updated the label for Altuviiio® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] to include full results from the phase 3 XTEND-Kids study showing...

WOBURN, Mass. May 6, 2024 – Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug...

RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's...

April 19, 2024 -- The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg for the emergency treatmentof known or suspected opioid overdose, as manifested by respiratory and/or central nervous system...

SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral granules formulation of Ingrezza...

FOSTER CITY, Calif.--(BUSINESS WIRE) April 26, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of...

VAUGHAN, Ontario, April 26, 2024 – Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. Food and Drug...

NEW YORK & COPENHAGEN, Denmark--(BUSINESS WIRE) April 29, 2024 -- Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves the supplemental Biologics License Application (sBLA)...

April 4, 2024 -- The U.S. Food and Drug Administration (FDA) has approved Xromi, an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6...

DURHAM, N.C., April 29, 2024 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug...

WARREN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives...

BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has approved...

NEW YORK--(BUSINESS WIRE) April 26, 2024 -- Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe...

Basel, April 23, 2024 -- Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and...

April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus...

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing...

CULVER CITY, Calif., April 22, 2024 -- ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus...

South San Francisco, CA -- April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment...