R3 Stem Cell says it is unaware of any safety concerns resulting from stem cell contamination as raised in an FDA Notice of Violation.
FDA grants Palatin Technologies an orphan drug designation for PL-8177 for treating non-infectious intermediate, posterior, pan and chronic anterior u...
Six stakeholders comment on an FDA docket on the future of biosimilar insulins.
FDA approves a DT MedTech PMA for the Hintermann Series H3 Total Ankle Replacement System.
Liver toxicity concerns prompt FDA to require an additional clinical trial before it can approve Motix Bios NDA for iclaprim, indicated for treating a...
Law professor Yaniv Heled raises concerns about the success potential of an FDA guidance on interchangeable biologics to lower drug costs.
Mallinckrodt reaches an agreement in principle with the Justice Department to resolve False Claims Act allegations that it paid illegal kickbacks to d...
Tempus announces its new TIME service to boost participation in cancer clinical trials.