Harrison Gunn

Goodwin

+ Follow Contact

Latest Posts › Food and Drug Administration (FDA)

Share:

FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA. SCD is a group of inherited...more

12/15/2023 / Biologics , CRISPR , FDA Approval , Food and Drug Administration (FDA) , Intellectual Property Protection , Life Sciences , Pharmaceutical Industry , Pharmaceutical Patents

Outlook Therapeutics to Revise Ophthalmic Bevacizumab BLA in Light of FDA Request

Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA. LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection...more

6/1/2022 / Biologics , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...more

3/22/2022 / Biosimilars , BsUFA , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Public Meetings

Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo. Susvimo is a refillable ocular implant - requiring refills every six months - that continuously delivers...more

11/8/2021 / Coherus , FDA Approval , Food and Drug Administration (FDA) , Hoffman LaRoche , Joint Venture , Pharmaceutical Industry , Prescription Drugs

FDA Accepts BeiGene’s BLA for Tislelizumab in Esophageal Squamous Cell Carcinoma

On September 13, 2021 BeiGene announced the FDA’s acceptance of its BLA for tislelizumab in esophageal squamous cell carcinoma (ESCC). While tislelizumab is already approved for five indications in China, this marks the first...more

9/28/2021 / Biologics , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

5 Results

View per page

Page: of 1