Novo Nordisk’s Ozempic Gets FDA Approval as Kidney-Disease Treatment
Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type ...
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides a Corporate Update
Reported a robust objective response rate of 75.5% from the Phase 1 study of NX-5948 in patients with relapsed/refractory CLL/SLL at the 66th ...
NL Times5d
European Medicines Agency ditches Elon Musk’s X in favor of Bluesky
The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...
GlobalData on MSN4h
FDA gives RMAT designation to Beacon’s retinitis pigmentosa treatment
The FDA has granted RMAT designation to Beacon Therapeutics’ gene therapy, laru-zova, for treating X-linked retinitis pigmentosa (XLRP).
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FDA Approves Ozempic for Kidney and Heart Protection in Diabetic Patients
The U.S. Food and Drug Administration (FDA) has approved Novo Nordisks (NYSE:NVO) Ozempic for reducing the risk of kidney ...
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EMA Shifts Digital Platform from X to Bluesky Amid Content Concerns
The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back ...
Managed Healthcare Executive5d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
Sarepta Therapeutics’ Strong Market Position and Elevidys’ Promising Prospects Drive Buy Rating
In a report released yesterday, Kostas Biliouris from BMO Capital maintained a Buy rating on Sarepta Therapeutics (SRPT – Research Report), ...
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...