Chester County News and Community Website
MALVERN, PA — Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) recenlty accepted the company’s New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic …
FDA Accepts Venatorx Pharmaceuticals’ New Drug Application for Cefepime-Taniborbactam Read More
HORSHAM, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food & Drug Administration (FDA) recently approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action …
FDA Approval: AKEEGA, the Game-Changing Dual Action Tablet for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer Treatment Read More HORSHAM, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food & Drug Administration (FDA) recently approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual-action …
FDA Approves AKEEGA: First Dual Action Tablet for BRCA-positive mCRPC Treatment Read More HORSHAM, PA — The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TALVEY™ (talquetamab-tgvs), a first-in-class …
FDA Approves TALVEY (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma Read More
The U.S. Food and Drug Administration issued a draft guidance which, once finalized, will assist cosmetics companies in submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to …
FDA Boosting Oversight for Safer Cosmetics: Strengthening Efforts for Consumer Safety Read More
MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) announced that it recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New …
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese Read More
The U.S. Food and Drug Administration recently approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs …
FDA Approves Zurzuvae: Game-Changing Medication for Postpartum Depression Read More
WAYNE, PA — Teleflex Incorporated (NYSE: TFX) announced the U.S Food and Drug Administration (FDA) has cleared the QuikClot Control+™ Hemostatic Device to include mild and moderate bleeding in cardiac …
Teleflex Announces FDA Clearance for QuikClot Control+™ Device to Address Bleeding in Cardiac Surgical Procedures Read More
BERWYN, PA — AscellaHealth recently released its Q2 2023 Specialty & Rare Pipeline Digest™, the industry’s most comprehensive resource on new, pending and projected Specialty and Rare Disease drug launches, …
AscellaHealth Releases Q2 2023 Specialty & Rare Pipeline Digest Read More
The U.S. Food and Drug Administration recently approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid …
FDA Approves RiVive: Nasal Spray for Opioid Overdose Prevention Goes Over-the-Counter Read More