February 2nd Week, 2026 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD 's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults wi

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

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

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

April 2nd Week, 2025 Regulatory Events   🎯 AstraZeneca  and  Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) mono has been approved...

March 3rd Week, 2025 Regulatory Events   🎯 The US FDA granted traditional approval to Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) +...

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive...