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Food and Drug Administration

Incyte
Regional

FDA Approves Monjuvi for Treating Relapsed or Refractory Follicular Lymphoma

June 22, 2025June 21, 2025 - by Timothy Alexander

WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory …

FDA Approves Monjuvi for Treating Relapsed or Refractory Follicular Lymphoma Read More

CSL
Regional

FDA Approves ANDEMBRY® for Preventing Hereditary Angioedema Attacks

June 18, 2025June 17, 2025 - by Timothy Alexander

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
Ocugen
Research

Ocugen Receives FDA Clearance for Phase 2/3 Trial of Genetic Therapy for Stargardt Disease

June 17, 2025June 17, 2025 - by Timothy Alexander

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

Palvella Therapeutics
Business

Palvella Therapeutics Secures FDA Grant Funding for Phase 3 Trial of QTORIN Rapamycin

June 11, 2025June 10, 2025 - by Timothy Alexander

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
FDA
National / Technology

Revolutionizing FDA Operations: Meet Elsa, the AI Tool Transforming Public Health

June 8, 2025June 7, 2025 - by Maryann Pugh

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

Savara
Regional

FDA Requests Additional Data for Savara’s MOLBREEVI Application

June 2, 2025June 1, 2025 - by Timothy Alexander

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
Facet Life Sciences
Strategic Combinations

Facet Life Sciences Announces Partnership with Nucleus for Regulatory Support

May 31, 2025May 30, 2025 - by Timothy Alexander

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

Traws Pharma
Regional

Traws Pharma Receives FDA Feedback on Flu Drug Development

May 29, 2025May 28, 2025 - by Timothy Alexander

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
Ocugen
Products and Services

Ocugen Receives Rare Pediatric Disease Designation for OCU410ST

May 29, 2025May 28, 2025 - by Timothy Alexander

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
GSK plc
Regional

FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype

May 28, 2025May 27, 2025 - by Timothy Alexander

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

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