EMA

Key TakeawaysFacilitates centralized reporting, reducing administrative burdens on MAHs Enhances real-time data availability for quicker response to shortages Improves coordination between EMA, national...

key TakewaysStreamlined access to RWD can accelerate medical research and regulatory approvals. Implementing Target Trial Emulation reduces bias, leading to more accurate conclusions. ...

Key TakeawaysOpdivo-Yervoy combination offers a novel first-line treatment option for MSI-H/dMMR metastatic colorectal cancer. Enhanced survival rates could set a new standard in...

Key TakeawaysPositive CHMP opinion for Opdivo® and Yervoy® as first-line treatment for metastatic colorectal cancer. The CheckMate -8HW trial showed a 79% reduction...

Critical Takeaways Key insights from the CVMP meeting include:Carprofen Orion stands out as a versatile solution for managing pain in pets during surgery. Revisions...

key TakeawaysDupixent is now the first approved treatment for young EoE patients in the EU. The medication showed significant improvement in disease symptoms...

Key TakeawaysAstraZeneca’s Wainzua (eplontersen) recommended for EU approval for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) with polyneuropathy. NEURO-TTRansform trial shows Wainzua improves neuropathy impairment...

Recent global health concerns have spotlighted mpox, a viral disease endemic to parts of Central and West Africa, as a significant threat. As cases...

In a notable advancement, Pliant Therapeutics, Inc., a prominent player in the biotechnology sector focused on fibrotic disease treatments, has announced promising results from...

Key TakeawaysThe European Medicines Agency (EMA) has recommended ten new medicines for approval, addressing a wide range of medical needs across the EU. ...

In a decisive move that underscores the European Union's commitment to health and research, the European Parliament has voted against the proposed budget cuts...

Key TakeawaysThe EMA has reaffirmed its decision not to renew the marketing authorisation for Translarna, citing insufficient evidence of its efficacy in Duchenne...

Key Takeaways Novartis' Kisqali® (ribociclib) has received a positive opinion from the European Medicines Agency's (EMA) CHMP, marking it as a potential treatment for hormone...

Key TakeawaysNovo Nordisk's Alhemo® (concizumab) has received a positive opinion from the European Medicines Agency (EMA), marking it as the first once-daily subcutaneous...

Key TakeawaysTearCare treatment significantly improves reading speed and vision-related quality of life in patients with dry eye disease. Patients report improved visual function,...