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

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC ( Ref ) The US...

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

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (...

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...

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

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

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC ( Ref ) The European Commission granted marketing...

July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for  Dizal Pharmaceutical ’s sunvozertinib (EGFR TKI)...

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

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

June 4th Week,2025 Regulatory Events   🎯  Daiichi Sankyo  and  AstraZeneca 's Dato-DXd (Datroway; TROP2 ADC) has been granted an...

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

June 3rd Week , 2025 Regulatory Events   🎯 The US FDA approved the updated labelling of  Pfizer ’s talazoparib (PARP inhibitor) +...

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

June 1st Week, 2025 Regulatory Events 🎯  Takeda  and  Pfizer ’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been...

May 5th Week, 2025 Regulatory Events 🎯 The EC approved  Bristol Myers Squibb ’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1)...

May 4th Week, 2025 Regulatory Events   🎯 The US FDA granted a Fast Track designation to  CSPC Pharmaceutical Group  ’s CPO301 (SYS6010;...

May 3rd Week, 2025 Regulatory Events   🎯  Incyte  and  MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been...