FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause
TOKYO, May 13 2023– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura,“Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved Veozah (fezolinetant) 45 mg once daily for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 13, 2023 Category: Drugs & Pharmacology Source Type: news
Otsuka and Lundbeck Announce U.S. FDA Approval of Supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer ’s Disease
PRINCETON, NJ and DEERFIELD, IL– May 10, 2023– Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Lundbeck LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Adult Patients with Fabry Disease
BOSTON and CARMIEL, Israel, May 10, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 10, 2023 Category: Drugs & Pharmacology Source Type: news
Farxiga Extended in the US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Failure to a Broader Range of Patients
May 9, 2023 -- AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF. The approval by... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 9, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis
NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 8, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Arexvy (respiratory syncytial virus vaccine, adjuvanted) Respiratory Syncytial Virus (RSV) Vaccine for Older Adults
May 3, 2023 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 3, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy
DUBLIN, May 01, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food& Drug Administration (FDA) has granted... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Final Approval of Lumryz (sodium oxybate) for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy
DUBLIN, May 01, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food& Drug Administration (FDA) has granted... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 1, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Abilify Asimtufii (aripiprazole) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
April 28, 2023 -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Abilify Asimtufii® (aripiprazole)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Once-Weekly Sogroya for the Treatment of Children Living with Growth Hormone Deficiency
PLAINSBORO, NJ, April 28, 2023– Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults
PARSIPPANY, N.J., TEL AVIV& PARIS, April 28, 2023– Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 28, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Prevnar 20, Pfizer ’s 20-Valent Pneumococcal Conjugate Vaccine for Infants and Children
NEW YORK--(BUSINESS WIRE) April 27, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Prevnar 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 27, 2023 Category: Drugs & Pharmacology Source Type: news
Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 2 Through 5 With Certain Mutations
BOSTON--(BUSINESS WIRE)--Apr. 26, 2023-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Vowst (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI
CAMBRIDGE, Mass.& HOBOKEN, N.J.--(BUSINESS WIRE)--Apr. 26, 2023-- Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced the U.S. Food and Drug Administration (FDA) approval of Vowst (fecal microbiota... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis Associated with a Mutation in the SOD1 Gene
CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved Qalsody (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 25, 2023 Category: Drugs & Pharmacology Source Type: news
