FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.
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.
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FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.
FDA clears a NovaBone Products 510(k) for its NovaBone Putty and its expanded use in the intervertebral disc space.
