FDA publishes a draft guidance with CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and ...
FDA approves Mylans generic Symbicort for asthma and COPD patients.
A Senate pandemic-related bill that outlines many new FDA responsibilities heads to the Senate floor for a vote after being marked-up 3/15 by Health, ...
Pfizer and BioNTech file an Emergency Use Authorization application for a second Covid-19 vaccine booster dose in adults 65 years of age and older who...
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RTPCR Diagnostic Pa...
Federal Register notice: FDA makes available a final guidance entitled Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier V...
FDA sends AstraZeneca a complete response letter on its supplemental BLA for Fasenra (benralizumab) for patients with inadequately controlled chronic ...
Federal Register notice: FDA determines that GE Healthcares MPI DMSA kidney reagent (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn fr...