18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia ( Ref ) The US FDA granted the Orphan Drug...

July 3rd Week, 2025 Regulatory Updates   🎯  Corcept Therapeutics  submitted an NDA to the US FDA for relacorilant (selective cortisol...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC ( Ref ) The first patient...

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US ( Ref ) Shanghai Henlius Biotech announced...

July 2nd Week, 2025 Regulatory Updates   🎯 The EC approved  BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer ( Ref ) Cel-Sci...

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA ( Ref ) The US FDA granted the...

08/07/2025 Adagene and ConjugateBio sign a partnership agreement to develop novel ADC ( Ref ) Adagene announced a partnership with...

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC ( Ref ) The US FDA approved Sirtex Medical's SIR-Spheres...

⭐ Summit Therapeutics, Inc.  has reportedly been in partnership discussions with  AstraZeneca  and other major pharma companies for its...

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer ( Ref ) AstraZeneca’s...

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma ( Ref ) Regeneron Pharmaceuticals announced...

01/07/2025 HanchorBio and Henlius signed a ~$200M licensing deal for HanchorBio's HCB101 ( Ref ) HanchorBio and Shanghai Henlius Biotech...

📢  AbbVie  is set to acquire  University of Pennsylvania ’s spinout,  Capstan Therapeutics  for up to $2.1 billion in cash, representing...

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab...

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA ( Ref ) CARsgen Therapeutics submitted the New Drug...

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma ( Ref )...

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...

Highlights from the CHMP June 2025 Meeting are out! New Medicines 💊  Cordex Biologics ' (an  ExCellThera  company) dorocubicel...