02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer ( Ref ) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA

13/02/2026 HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer HanchorBio's HCB101 received the FDA orphan drug designation for gastric cancer ( Ref ) The US FDA granted the Orphan Drug Designation to HanchorBio's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes HCB101 is currently being

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults wi

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer ( Ref ) Daiichi Sankyo and...

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer ( Ref ) The US FDA...

23/07/2025 Roche's Itovebi regimen received approval in the EU for ER-positive, HER2-negative, advanced breast cancer with a PIK3CA...