Highlights from the CHMP Feb 2026 Meeting are out! New Medicines 💊  Ipsen 's tovorafenib (Ojemda; Type II RAF kinase inhibitor) is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies New Biosimilars 💊  Henlius  and  Organon 's pertuzumab (Poherdy; HER2/neu receptor antagonist), an

Bristol Myers Squibb 's Q4 2025 earnings call spotlighted key milestones for the Opdualag franchise in melanoma 📊 Blockbuster Status and US Dominance Four years post-launch, Opdualag reached blockbuster status with 2025 global revenues of $1,185M, driven by $1,045M in the US. It has captured over 30% US market share, cementing its role as a standard-of-care option for metastatic melanoma. The ex-US market remains largely untapped with sales generating only $140M, constrained

Highlights from the CHMP Jan 2026 Meeting are out! Indication Expansions 💊  Johnson & Johnson Innovative Medicine 's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic) 💊  Incyte  and  Takeda 's ponatinib (I

07/01/2026 Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer   Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer ( Ref ) The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. Dr Linda Wu, CDO, Arbele: " Orphan Drug Designation for ARB10

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...

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma ( Ref )...

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

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...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...