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FDA Approves Novartis Drug for Rare Kidney Disease Treatment
Novartis NVS announced that the FDA has approved Fabhalta (iptacopan) for a third indication. The regulatory body approved ...
The Pharma Letter8d
EMA annual report 2024
At its March meeting, the European Medicines Agency’s management board adopted the EMA’s annual report for 2024. This ...
pharmaphorum2d
EMA’s strategy for speeding up drug approvals in the EU
With the average R&D cost for drug development being $2.3 ... The conclusion of the agency’s review sees the EMA plan to tackle delays in medicine approval by enhancing both submission ...
EL PAÍS English10d
The most expensive drug ever approved: A gene therapy that cures butterfly skin and could cost $20 million per patient
Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...
Business Wire26d
European Medicines Agency Validates Gilead’s Marketing Authorization Application and EU-Medicines for All Application for Twice-Yearly Lenacapavir for HIV Prevention
including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be ...
MedPage Today9d
Approved Sickle Cell Drug Fails to Beat Placebo in Trial
SUSTAIN was the basis for FDA approval and European Medicines Agency (EMA) approval for crizanlizumab for the prevention of vaso-occlusive crises in patients ages 16 years and older with sickle ...
Yahoo Finance4d
Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa ...
Reuters23d
EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
Feb 28 (Reuters) - The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab Alzheimer's drug ...
PathAI Announces EMA Qualification for AIM-MASH AI Assist, a Groundbreaking AI Tool for MASH Clinical Trials
PathAI, a global leader in AI-powered pathology, today announced that the European Medicines Agency (EMA) Committee for ...
TMCnet4d
Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven ...