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KING OF PRUSSIA, PA — The U.S. Food and Drug Administration (FDA) has approved ANDEMBRY® (garadacimab-gxii), developed by CSL, as the first treatment targeting factor XIIa for the prevention of …
FDA Approves ANDEMBRY® for Preventing Hereditary Angioedema Attacks Read More
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 2/3 pivotal confirmatory trial of OCU410ST, an innovative …
Ocugen Receives FDA Clearance for Phase 2/3 Trial of Genetic Therapy for Stargardt Disease Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) has received the initial proceeds from a prestigious FDA Orphan Products Development grant to support its ongoing Phase 3 SELVA trial of …
Palvella Therapeutics Secures FDA Grant Funding for Phase 3 Trial of QTORIN Rapamycin Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the official launch of Elsa, a cutting-edge generative Artificial Intelligence (AI) tool designed to optimize efficiency across the …
Revolutionizing FDA Operations: Meet Elsa, the AI Tool Transforming Public Health Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced receiving a Refuse-to-File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) of MOLBREEVI, …
FDA Requests Additional Data for Savara’s MOLBREEVI Application Read More
PHOENIXVILLE, PA — Facet Life Sciences, a firm specializing in regulatory guidance for life science companies, has announced its partnership with Nucleus, a leader in diagnostic and therapeutic radiopharmaceuticals. Facet …
Facet Life Sciences Announces Partnership with Nucleus for Regulatory Support Read More
NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) announced receipt of key guidance from the U.S. Food and Drug Administration (FDA) regarding the development of its investigational antiviral, tivoxavir marboxil …
Traws Pharma Receives FDA Feedback on Flu Drug Development Read More MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for its investigational therapy OCU410ST, aimed …
Ocugen Receives Rare Pediatric Disease Designation for OCU410ST Read More
PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) with …
FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid data. The …
FDA Takes Action Against Third-Party Testing Labs Over Falsified Data Read More