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FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
US FDA approves Regeneron's blood cancer therapy
Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood ...
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FDA approves Regeneron drug to treat multiple myeloma
Regeneron Pharmaceuticals has received accelerated FDA approval for Lynozyfic, a new bispecific antibody treatment for adults with relapsed or refractory multiple myeloma who have undergone at least ...
How we plan to cut FDA drug approval time by months
Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...
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FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug
Regeneron Pharmaceuticals, Inc. REGN obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory ...
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FDA approves first-ever drug for macrophage activation syndrome in Still’s disease
The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...
FDA-approved drug may also treat alcoholism and withdrawal pain
A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity.
FDA Approves ‘Breakthough’ Drug to Prevent HIV
In clinical trials, researchers found Yeztugo to be highly effective as a twice-yearly form of pre-exposure prophylaxis.
HIV prevention drug lenacapavir approved by FDA as twice-yearly injection
Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...