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
FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis
Brussels (Belgium), 18 OCTOBER 2023– UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of moderate to severe plaque... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Maxigesic IV to be Marketed in the U.S. as Combogesic IV (acetaminophen and ibuprofen) for the Management of Pain
Maxigesic® IV, a potent non-opioid painkiller, to be marketed in the U.S. under the tradename Combogesic® IV
Liège, Belgium– 18 OCTOBER 2023 - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia
PONTE VEDRA, Fla., Oct. 18, 2023 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, 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 - October 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Xphozah (tenapanor) to Reduce Serum Phosphorus in Adults with Chronic Kidney Disease
WALTHAM, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis
ATLANTA, Oct. 17, 2023 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Zilbrysq® (zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With Resectable NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Single Agent as Adjuvant Treatment After Surgery
RAHWAY, N.J.--(BUSINESS WIRE) October 16, 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, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. Food and Drug Administration Approves Opdivo (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma
In the Phase 3 CheckMate -76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to placebo1
CheckMate -76K marks the fifth Opdivo-based indication in earlier stages of cancer, in the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 13, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Velsipity (etrasimod) for Adults with Moderately to Severely Active Ulcerative Colitis (UC)
NEW YORK--(BUSINESS WIRE) October 13, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Velsipity™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 13, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Braftovi (encorafenib) with Mektovi (binimetinib) for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation
NEW YORK--(BUSINESS WIRE) October 12, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Braftovi® (encorafenib) + Mektovi® (binimetinib) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 11, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Arcutis ’ Zoryve (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
WESTLAKE VILLAGE, Calif., Oct. 06, 2023 (GLOBE NEWSWIRE)— Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 6, 2023 Category: Drugs & Pharmacology Source Type: news
