October 5th Week, 2025 Regulatory Events   🎯 The EC approved Merck & Co./  MSD 's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./ MSD  and  Eisai US  reported that the Phase 3 LITESPARK-011 trial of b

October 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved  Regeneron 's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm of this indication? 🎯 The US FDA accepted for Priority Review  Orca Bio 's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignanci

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

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

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

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...

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) +...

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

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

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

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

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...