17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma ( Ref ) The European Commission grant

Highlights from the CHMP Dec 2025 Meeting are out! New Medicines 💊 Conditional marketing authorisation of  ImmunityBio, Inc. 's nogapendekin alfa inbakicept (Anktiva: IL-15 superagonist complex) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours 💊  Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ’s aumolertinib (Au

Highlights from the CHMP Nov 2025 Meeting are out! New Medicines 💊  Eli Lilly and Company 's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. New Hybrid Medicines 💊  Accord Healthcare 's enzalutamide (Enzalutamide Ac

Highlights from the CHMP Oct 2025 Meeting are out! Indication Expansions 💊  Bristol Myers Squibb 's lisocabtagene maraleucel (Breyanzi; autologous CD19-directed CAR T-cell therapy) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor 💊  CStone Pharmaceuticals  and  Ewopharma 's sugemalimab (Cejemly; anti-PD-L1) as monotherapy i

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊  Teva Pharmaceuticals ' Degevma (RANKL inhibitor; denosumab...

Highlights from the CHMP July 2025 Meeting are out! New Medicines 💊  Servier 's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for...

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer ( Ref ) AstraZeneca’s...

Highlights from the CHMP June 2025 Meeting are out! New Medicines 💊  Cordex Biologics ' (an  ExCellThera  company) dorocubicel...

May 5th & June 1st Week ⭐ Regulatory Updates   🎯 China’s NMPA granted Priority Review to  CARsgen Therapeutics ’ satri-cel (CT041; an...

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊  Autolus Therapeutics ' obecabtagene autoleucel (Aucatzyl; CD19...

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