October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Jazz Pharmaceuticals ' lurbinectedin (DNA alkylating agent) +  Roche 's...

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved  Eli Lilly and Company 's imlunestrant (oral estrogen receptor...

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...

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast...

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA ( Ref ) China's NMPA has accepted Sichuan...

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD ’s Keytruda Qlex (subcutaneous injection of...

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊  Teva Pharmaceuticals ' Degevma (RANKL inhibitor; denosumab...

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

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved  Boehringer Ingelheim ’s zongertinib (HER2-selective tyrosine kinase...

August 4th Week, 2025 Regulatory Events   🎯 The EC approved  BeOne Medicines ' tislelizumab (anti-PD-1) + platinum-containing chemo as...

August 4th Week, 2025 Regulatory Events   🎯 Health Canada issued a NOC/c for  Iovance Biotherapeutics, Inc. 's lifileucel (autologous...

August 3rd Week, 2025 Regulatory Events   🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 ( Ref ) Health...

August 2nd Week, 2025 Regulatory Events   🎯 The US FDA granted accelerated approval to  Boehringer Ingelheim 's zongertinib (kinase...

August 1st Week, 2025 Regulatory Events   🎯  AbbVie  submitted a sNDA to the US FDA for AbbVie and  Roche ’s venetoclax (BCL-2...

July 4th Week, 2025 Regulatory Events   🎯 The EC approved  Bayer  and  Orion Pharma ’s darolutamide (androgen receptor inhibitor) +...

Highlights from the CHMP July 2025 Meeting are out! New Medicines 💊  Servier 's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for...