Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for ...
In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also ...
Le Lézard16 小时
U.S. FDA Accepts Gilead's New Drug Applications for Twice-Yearly Lenacapavir for HIV ...
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir?the company's twice-yearly injectable HIV ...
Jaguar Health Extends Collaboration for Possible Tropical Disease Priority Review Voucher ...
Priority Review Vouchers (PRVs) are transferable and, in past transactions by other companies, have sold for prices up to $350 million1.3 to 4 ...
Azorobotics4 天
How the United States AI Regulatory Landscape Differs from the EU and UK
AI companies in the US operate within a complex regulatory landscape shaped by multiple agencies and industry-specific laws.
pharmaphorum1 天
After FDA nod, Eisai and Biogen file lecanemab in EU
Eisai and Biogen have moved swiftly ahead with regulatory filings for their new Alzheimer's therapy lecanemab in the EU, after getting ... application with the FDA, that will try to covert the ...
pharmaphorum1 天
After FDA no, Regeneron gets yes from EU on odronextamab
Regeneron's CD20xCD3 bispecific antibody for non-Hodgin lymphoma (NHL) has been approved in Europe, five months after it was turned down by the FDA in the ... cleared in the EU for the same ...
Today2 天
Granola bar recall: FDA updates recall for over 2 million MadeGood granola bars
The U.S. Food and Drug Administration has made an update to its MadeGood granola bar recall. The popular granola bars, sold on Amazon and in stores like Target, Whole Foods, Wegmans, CVS, among ...
Today2 天
FDA sets highest risk level for popular pancake and waffle mix recall
At that time, no allergic reactions related to recall were reported. On Feb. 13, the FDA classified the recall of the pancake and waffle mix to the highest level, a Class I. The FDA defines a ...
Yahoo Finance4 天
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar ...
Newsday2 天
Trump administration cuts reach FDA employees in food safety, medical devices and tobacco ...
Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of ...
Bispecific Antibody Market Expands with Over 600 Clinical Trials – New Patent Analysis ...
Innovative Bispecific Antibody Therapies in Cancer Treatment Emerge as Patent Filings SurgeDublin, Feb. 18, 2025 (GLOBE NEWSWIRE) -- The "Bispecific Antibody & Cancer Patent Landscape Analysis" report ...
Food Safety News5 天
Publisher’s Platform: FDA closes romaine lettuce outbreak with 89 sick and says nothing more?
With no fanfare after 89 reported sick, the FDA has closed its investigation into a romaine lettuce E. coli outbreak without telling the public more and the CDC continues to remain mum.