- Apnimed files for IPO as FDA reviews its sleep apnea drugApnimed is finally going forward with an IPO attempt after years of flirting with the milestone. The Cambridge, MA-based biotech revealed its Nasdaq plans on Friday night, following a strong six ...Endpoints · 14d ago↗ source
- FDA returns to releasing pharma rejection letters with 14 new CRLsThe FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...Endpoints · 14d ago↗ source
- FDA rejects Hengrui-Elevar liver cancer drug combo for third timeFor the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…