FDA Approves Myhibbin (mycophenolate mofetil) Oral Suspension for Prophylaxis of Organ Rejection
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 6, 2024 Category: Drugs & Pharmacology Source Type: news
US FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo (adalimumab-adbm) injection
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 2, 2024 Category: Drugs & Pharmacology Source Type: news
Neurocrine Biosciences Announces U.S. FDA Approval of Ingrezza Sprinkle (valbenazine) Capsules
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Libervant (diazepam) Buccal Film for the Treatment of Seizure Clusters in Pediatric Patients Ages 2-5 Years
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Xolremdi (mavorixafor) for Use in Patients with WHIM Syndrome
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Full Approval for Tivdak to Treat Recurrent or Metastatic Cervical Cancer
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)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Hercessi (trastuzumab-strf), a Biosimilar to Herceptin
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 29, 2024 Category: Drugs & Pharmacology Source Type: news
Bausch + Lomb Receives FDA Approval of Lumify Preservative Free Redness Reliever Eye Drops
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Biktarvy Label Update With Data for Pregnant Adults With HIV
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2024 Category: Drugs & Pharmacology Source Type: news
Novartis Radioligand Therapy Lutathera FDA Approved as First Medicine Specifically for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 22, 2024 Category: Drugs & Pharmacology Source Type: news
FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose
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... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 19, 2024 Category: Drugs & Pharmacology Source Type: news
