post marketing

Biotech

Biogen to navigate an ethics minefield for post-approval trial

After the Aduhelm approval set a precedent for FDA clearance based on surrogate endpoints, all eyes will be on Biogen's post-approval study.
Amirah Al Idrus Jun 23, 2021 8:54am

FDA warns Allergan over recalled breast implant safety studies

May 15, 2020 9:45am

FDA warns 2 breast implant makers as safety probe continues

Mar 20, 2019 10:54am

FDA to launch scientific review of implant biocompatibility

Mar 15, 2019 4:54pm

Bayer, FDA extend Essure postmarket safety study by 2 years

Dec 27, 2018 2:20pm

Alcon pulls eye micro-stent from market after new safety data

Aug 30, 2018 7:59am