Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
- FDA Grants Accelerated Approval to Ziihera (zanidatamab-hrii) for the Treatment of HER2-Positive Biliary Tract Canceron November 20, 2024 at 2:11 am
DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the...
- UCB Receives U.S. FDA Approval for Bimzelx (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate to Severe Hidradenitis Suppurativaon November 20, 2024 at 1:11 am
Brussels (Belgium), November 20, 2024 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults...
- FDA Approves Revuforj (revumenib) for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocationon November 15, 2024 at 12:11 am
WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of...
- FDA Approves Danziten (nilotinib) Tablets, the First and Only Nilotinib With No Mealtime Restrictionson November 14, 2024 at 1:11 am
WOBURN, Mass. Nov 14, 2024 – Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly...
- FDA Approves Kebilidi (eladocagene exuparvovec-tneq) Gene Therapy for the Treatment of AADC Deficiencyon November 13, 2024 at 2:11 am
WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy...
- FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemiaon November 8, 2024 at 9:11 pm
LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the U.S. Food and Drug Administration...
- FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of Rosaceaon November 4, 2024 at 12:11 am
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug...
- Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indicationson October 29, 2024 at 10:10 am
CAMBRIDGE, Mass.--(BUSINESS WIRE) October 29, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has expanded the approval of Jylamvo...
- Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CMLon October 29, 2024 at 10:10 am
East Hanover, October 29, 2024 – Novartis announced today that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic...
- Protega Pharmaceuticals Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Painon October 29, 2024 at 9:10 am
PRINCETON, N.J., Oct. 29, 2024 /PRNewswire/ -- Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company focused on responsible pain management and the development of novel abuse-deterrent products, announced today that the U.S...
- FDA Approves Orlynvah (sulopenem etzadroxil and probenecid) for the Treatment of Uncomplicated Urinary Tract Infectionson October 25, 2024 at 9:10 pm
DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for Orlynvah (sulopenem...
- U.S. FDA Approves Pfizer’s RSV Vaccine Abrysvo for Adults Aged 18 to 59 at Increased Risk for Diseaseon October 22, 2024 at 5:10 am
NEW YORK--(BUSINESS WIRE) October 22, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF)...
- Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of Selarsdi (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara (ustekinumab)on October 22, 2024 at 4:10 am
REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug...
- FDA Approves Vyloy (zolbetuximab-clzb) for the Treatment of Advanced Gastric and GEJ Canceron October 21, 2024 at 1:10 am
TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with...
- Botox Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)on October 18, 2024 at 12:10 am
IRVINE, Calif., Oct. 18, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Botox Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting...
- FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Diseaseon October 17, 2024 at 9:10 pm
NORTH CHICAGO, Ill., Oct. 17, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of...
- Avadel Pharmaceuticals Announces FDA Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with Narcolepsyon October 17, 2024 at 3:10 am
DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) has approved its...
- UCB Receives U.S. FDA Approval for 320 mg Single-Injection Device Presentations of Bimzelx (bimekizumab-bkzx)on October 14, 2024 at 10:10 pm
Brussels (Belgium), October 14, 2024 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each...
- FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelaraon October 14, 2024 at 8:10 pm
RALEIGH, N.C., Oct. 14, 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...
- FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitorson October 11, 2024 at 1:10 am
NEW YORK--(BUSINESS WIRE) October 11, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding...
