Highlights from the CHMP Mar 2026 Meeting are out! New Medicines 💊  Ferring Pharmaceuticals ’ nadofaragene firadenovec gene therapy for the Tx of adults with BCG-unresponsive NMIBC with CIS with/without papillary tumours 💊  Amgen 's tarlatamab (DLL3 x CD3 BsAb) for the Tx of adults with ES-SCLC, who require systemic therapy following disease progression on or after 1L Tx with platinum-based chemo 💊  PharmaMar  &  Jazz Pharmaceuticals ' lurbinectedin (alkylating agent) + at

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

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

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

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...

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 CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊  Jazz Pharmaceuticals  and  BeiGene 's zanidatamab (Ziihera; dual...

Highlights from the CHMP March 2025 Meeting are out!  ⭐ Indication Expansions :  💊  Pfizer 's bosutinib (Bosulif; second-generation...

Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space: ⭐ New Therapies: 👉...

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