Highlights from the CHMP Apr 2026 Meeting are out! New Generics 💊 Viatris' palbociclib (Palbociclib Viatris; CDK4/6 inhibitor) for the treatment of HR+ HER2- locally advanced or metastatic breast cancer either in in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy Indication Expansions 💊 Otsuka Pharmaceutical Companies (U.S.)'s fixed‑dose oral combination of decitabine‑cedazuridine (Inaqovi; hypom

December 4th Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Roche 's Lunsumio VELO (mosunetuzumab; CD20 x CD3 BsAb), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. (Ref 1) ❓ What are the key pros and cons of this subcutaneous therapy? Clinical Events 🔬 The Phase 3 LATIFY trial of AstraZeneca 's ceralasertib (ATR kinase inhibitor) +

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

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to Adcentrx Therapeutics ’ ADRX-0706 (Nectin-4...

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) +...