The FDA approval was based on an early-to-mid-stage study data that showed 51% of patients required no surgeries in the 12 months after the …
Tag:
FDA
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Generic drugmaker Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for Diltiazem Hydrochloride tablets USP, 30 mg, …
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Doctors are criticizing a recent expert panel organized by the U.S. Food and Drug Administration that questioned the safety of taking antidepressants during pregnancy. …
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Health
Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
On July 25, The European Medicines Agency (EMA)’s advisory committee recommended Gilead Sciences’ Lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and …
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Generic drugmaker Natco Pharma has received an establishment inspection report from the U.S. Food and Drug Administration for its active pharmaceutical ingredient manufacturing facility …
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The U.S. Food and Drug Administration has issued a warning letter to Glenmark Pharmaceuticals for the company’s manufacturing facility in Indore, Madhya Pradesh. …
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Politics
Maharashtra FDA suspends MLA hostel caterer’s licence after ‘stale food’ claim by Legislator
FDA inspectors raid Akashwani canteen serving MLA hostel near Mantralaya, after Shiv Sena leader Sanjay Gaikwad allegedly assaulted a staffer over poor food quality, …
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Over 36,000 new cases of multiple myeloma are estimated to be diagnosed in the U.S. in 2025, according to the American Cancer Society |Image …
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Generic drugmaker Granules India on Saturday said subsidiary Granules Pharmaceuticals Inc. addressed and resolved a U.S. Food and Drug Administration observation during the same …
