fda-and-biotech News
Replimune plunges 19% as investors await key FDA decision on melanoma therapy
PDUFA deadline arrives for RP1 treatment after July Complete Response Letter cited trial design issues, not safety concerns
ANI Pharmaceuticals jumps 3% after FDA approval of generic heart drug
Minnesota drugmaker launches limited-competition Isosorbide Mononitrate as generics segment drives record growth
Mesoblast gains FDA clearance for Ryoncil Duchenne trial
Direct-to-registrational path bypasses Phase 2 as biotech targets $6.6bn DMD market
Outlook Therapeutics wins FDA review after December rejection
Biotech company secures formal dispute resolution hearing for wet AMD treatment ONS-5010
Viridian crashes 24% as Amgen's TEPEZZA data upends TED market
Superior efficacy from subcutaneous formulation casts doubt on elegrobart's commercial prospects
Immunovant shares plunge 16% on Phase 3 trial failure
Batoclimab misses primary endpoint in thyroid eye disease studies, clearing path for TEPEZZA competitors
ORIC Pharmaceuticals crashes 41% on prostate cancer drug dose concerns
Lower Phase 3 dose selection raises questions about competitive position against Pfizer in prostate cancer treatment
Agios surges 20% on accelerated approval push for sickle cell drug
Biotech pursues FDA pathway for mitapivat in lucrative hematology market as Pyrukynd sales expand