November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial,  Iovance Biotherapeutics, Inc. ’s lifileuc

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved  Johnson & Johnson Innovative Medicine 's INLEXZO (TAR-200; gemcitabine...

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC ( Ref ) The US FDA approved Johnson & Johnson's INLEXZO™...

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 )...

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

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

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

June 2nd Week, 2025 Regulatory Events   🎯 The US FDA approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a...

May 1st Week, 2025 Regulatory Events   🎯  Summit Therapeutics, Inc.  and  Akeso Biopharma ’s ivonescimab (PD-1 x VEGF BsAb) mono has...

April 3rd Week, 2025 Regulatory Events   🎯  Bristol Myers Squibb ’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved...

March 4th Week, 2025 Regulatory Events 🎯  CStone Pharmaceuticals  submitted a Type II variation application to the EMA for sugemalimab...