On Thursday, the FDA cleared new versions of Pfizer's (PFE) and Moderna's (MRNA) COVID-19 vaccines that are designed to match COVID-19 strains currently circulating in the country.
Thursday, the FDA granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The approval comes for the updated vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE) / BioNTech SE (NASDAQ:BNTX). The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protectio
The FDA has lifted the partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate (ADC). This decision, announced on August 15, follows the submission of a complete response that includes data analysis, updated documentation, and additional risk mitigation measures, the company reported in an SEC filing. The MediLink-sponsored trial evaluates the early-stage antibody-drug conjugate product candidate BNT326/YL202 as a later-line treatm