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CHMP Updates - December'25
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
Oncofocus Team
Dec 15, 20251 min read


CHMP Updates - November'25
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
Oncofocus Team
Nov 19, 20251 min read


CHMP Updates - October'25
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
Oncofocus Team
Oct 22, 20251 min read


Oncology Updates - Key Oncology News
June 4th Week,2025 Regulatory Events 🎯 Daiichi Sankyo and AstraZeneca 's Dato-DXd (Datroway; TROP2 ADC) has been granted an...
Oncofocus Team
Jun 30, 20252 min read


Cell and Gene Therapy Updates
June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or...
Oncofocus Team
Jun 25, 20252 min read


Oncology Updates - Key Oncology News
March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb ’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by...
Oncofocus Team
Jun 23, 20252 min read


Oncology Updates - Key Oncology News
February 4th Week, 2025 📝 Merck & Co/ MSD 's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable,...
Oncofocus Team
Jun 23, 20252 min read


Cell and Gene Therapy Updates
June 2nd week, 2025 ⭐ Deals & Collaborations 🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary...
Oncofocus Team
Jun 23, 20252 min read


Cell and Gene Therapy Updates
February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for...
Oncofocus Team
Jun 20, 20251 min read


Cell and Gene Therapy Updates
February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met...
Oncofocus Team
Jun 20, 20252 min read


CHMP Updates - May'25
Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics ' obecabtagene autoleucel (Aucatzyl; CD19...
Oncofocus Team
Jun 20, 20252 min read


CHMP Updates - April'25
Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊 Jazz Pharmaceuticals and BeiGene 's zanidatamab (Ziihera; dual...
Oncofocus Team
Jun 20, 20251 min read


CHMP Updates - March'25
Highlights from the CHMP March 2025 Meeting are out! ⭐ Indication Expansions : 💊 Pfizer 's bosutinib (Bosulif; second-generation...
Oncofocus Team
Jun 20, 20251 min read


CHMP Updates - February'25
Highlights from the CHMP Feb 2025 Meeting are out! Here are the positive recommendations in the Oncology space: ⭐ New Therapies: 👉...
Oncofocus Team
Jun 20, 20252 min read
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