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FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.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.
Six Squire Patton Boggs attorneys lay out the impact of four recent Supreme Court decisions on several aspects of FDA regulation.
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...
Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula risks.
