Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devices internal flow se...
Two stakeholder trade associations suggest changes to an FDA strategy document on innovative manufacturing technologies.
President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health and Human Services.
DifGen asks FDA to require long-term refrigerated stability studies for any generic form of its Prednisolone Ophthalmic Solution 1%.
Federal Register notice: FDA announces a 12/13 virtual public workshop entitled Patient-Focused Drug Development: Workshop to Discuss Methodologic and...
Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoid/round cell liposar...
FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA.
FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.
