Federal Register notice: FDA determines that Tevas Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdraw...
Celgene submits a BLA for luspatercept, an erythroid maturation agent for treating adult patients with very low to intermediate risk myelodysplastic s...
Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals agree to pay a total of $122.6 million to resolve allegations that they each violated the ...
FDA posts a 24-page Form 483 from a 5/2018 inspection of Akorns Decatur, IL sterile drug manufacturing operation.
The Alliance for a Stronger FDA advocates for a 15% ($60 million) increase to President Trumps FY 2020 budget proposal that would boost funding by $41...
FDA clears an Avanos Medical 510(k) for its improved On-Q with Bolus pump for reducing postoperative opioid use to achieve pain management.
FDA issues a finalized guidance explaining how it applies statutory factors in determining when a REMS is needed to ensure a drugs benefits outweighs ...
Federal Register notice: FDA proposes a new information collection on Providing Regulatory Submissions in Electronic and Non-Electronic Format Promot...