FDA Approves Merck ’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 31, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Novartis' Cosentyx as the First New Biologic Treatment Option for Hidradenitis Suppurativa Patients in Nearly a Decade
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 31, 2023 Category: Drugs & Pharmacology Source Type: news
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 Adults
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.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 31, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Loqtorzi (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 27, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Genentech ’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
CORAL GABLES, Fla., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ( " Catalyst " or " Company " ) (Nasdaq: CPRX) today reported that Santhera Pharmaceuticals ( " Santhera " ) has obtained U.S. Food and Drug Administration ( " FDA " ) approval... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 26, 2023 Category: Drugs & Pharmacology Source Type: news
Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)
Tibsovo is the first and only approved targeted therapy for R/R MDS patients with a susceptible IDH1 mutation
Fifth approved indication for Tibsovo solidifies Servier ' s leadership in mutant IDH inhibition
BOSTON, Oct. 24, 2023 /PRNewswire/... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 24, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People With Inflammatory Bowel Disease
JERSEY CITY, N.J.--(BUSINESS WIRE) October 23, 2023 --Today, Celltrion USA announced that the U.S. Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 23, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris
LAVAL, Quebec, Oct. 20, 2023– Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administration (FDA) has approved the New... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Approves BioMarin's Voxzogo (vosoritide) for Children Under 5 Years with Achondroplasia
SAN RAFAEL, Calif., Oct. 20, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Expands Pediatric Indication for Rozlytrek (entrectinib) and Approves New Pellet Formulation
On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- 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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents
NEW YORK--(BUSINESS WIRE) October 20, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 20, 2023 Category: Drugs & Pharmacology Source Type: news
