Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- FDA Approves Ogsiveo (nirogacestat) for Adults with Desmoid Tumorson November 27, 2023 at 11:11 pm
STAMFORD, Conn., Nov. 27, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration...
- FDA Approves Ryzneuta (efbemalenograstim alfa) for Chemotherapy-Induced Neutropeniaon November 22, 2023 at 10:11 am
November 22, 2023, New Jersey – Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotech Biopharma (Acrotech), a New Jersey-based...
- FDA Approves Truqap (capivasertib) plus Faslodex for Patients with Advanced HR-Positive Breast Canceron November 17, 2023 at 7:11 pm
17 November 2023 -- AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or...
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinomaon November 16, 2023 at 8:11 pm
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone Approval marks seventh gastrointestinal cancer indication for...
- Pfizer and Astellas' Xtandi Approved by U.S. FDA in Earlier Prostate Cancer Treatment Settingon November 16, 2023 at 7:11 pm
TOKYO and NEW YORK, Nov. 16, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug...
- FDA Approves Augtyro (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)on November 16, 2023 at 2:11 am
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic...
- FDA Approves DefenCath (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patientson November 15, 2023 at 7:11 pm
Berkeley Heights, NJ – November 15, 2023 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and...
- Pacira Announces FDA Approval of Expanded Exparel Label to Include Two Additional Nerve Block Indicationson November 10, 2023 at 10:11 pm
Exparel is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies — New indications for use as an adductor canal block and sciatic nerve block in the...
- FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Viruson November 10, 2023 at 8:11 pm
Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved Ixchiq®, Valneva’s single-dose,...
- FDA Approves Adzynma (ADAMTS13, recombinant-krhn) Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)on November 9, 2023 at 5:11 pm
OSAKA, Japan & CAMBRIDGE, Mass., November 09, 2023--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Adzynma (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand...
- FDA Approves Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Canceron November 8, 2023 at 7:11 pm
OSAKA, Japan and CAMBRIDGE, Massachusetts, November 8, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib), an oral targeted therapy for adults...
- FDA Approves Zepbound (tirzepatide) for Chronic Weight Managementon November 8, 2023 at 5:11 pm
INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP...
- FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellituson November 6, 2023 at 8:11 pm
November 06, 2023, Ahmedabad, India -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application...
- FDA Approves Voquezna (vonoprazan) for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in Adultson November 1, 2023 at 10:11 pm
FLORHAM PARK, N.J., Nov. 01, 2023 (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....
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Canceron November 1, 2023 at 8:11 pm
RAHWAY, N.J.--(BUSINESS WIRE) November 1, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in...
- FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelaraon October 31, 2023 at 11:10 pm
October 31, 2023 -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat...
- FDA Approves Novartis' Cosentyx as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decadeon October 31, 2023 at 10:10 pm
FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor approved for HS, Cosentyx offers a meaningful new...
- Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adultson October 31, 2023 at 1:10 am
FLORHAM PARK, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced that the U.S....
- FDA Approves Loqtorzi (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)on October 27, 2023 at 10:10 pm
REDWOOD CITY, Calif. and SHANGHAI, China, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) today announced that...
- FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)on October 26, 2023 at 10:10 pm
RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema Approval is based on two Phase III studies demonstrating early and sustained vision improvements that were...
