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...

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