FDA News

FDA approves OTC Rextovy, broadening naloxone access for opioid overdose

FDA · opioid overdose · 6 min

Lilly buys 4E in non-opioid pain push: what investors should watch

FDA · moderate to severe acute pain · 6 min

Lilly’s early JAK data raises myelofibrosis competition question

FDA · myelofibrosis · 6 min

FDA authorizes emergency pet treatment for New World screwworm

FDA · New World screwworm · 4 min

FDA guidance on sharing potential NDA patent information: what changes now

FDA · 4 min

Hillhurst Bio doses first subject in Phase 2a HBI-002 Parkinson's trial

FDA · Parkinson's disease · 5 min

FDA expands Tzield to certain pediatric patients with recent Stage 3 T1D

FDA · diabetes · 5 min

FDA Approves Capivasertib for PTEN-Deficient Prostate Cancer

FDA · prostate cancer · 6 min

FDA approves belzutifan plus pembrolizumab for adjuvant RCC

FDA · renal cell carcinoma · 6 min

FDA MRD guidance in multiple myeloma: what BD teams should track

FDA · multiple myeloma · 6 min

FDA Draft Guidance Updates Payor Communications Rules

FDA · 4 min

Alembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules

FDA · NTRK fusion–positive solid tumors · 7 min