FDA

News and Updates by the Food and Drugs Administration (FDA)

FDA Sanctions Neurocrine Biosciences’ Crenessity for Treating Classic Congenital Adrenal Hyperplasia in Adults and Children

Neurocrine Biosciences, Inc., recognized for its neuroscience innovations, has announced the U.S. Food and Drug Administration’s endorsement of Crenessity (crinecerfont) as a supplementary therapy to glucocorticoid replacement. This approval is for the purpose of controlling androgen levels in adults and […]

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Zimmer Biomet’s OsseoFit Stemless Shoulder System Gains FDA Approval for Full Shoulder Replacement

Zimmer Biomet Holdings, Inc., a pioneer in medical technology worldwide, announced that their OsseoFit Stemless Shoulder System has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in total shoulder replacement procedures. This state-of-the-art implant is

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Collaboration Between Boehringer Ingelheim and Vétérinaires Sans Frontières Germany to Combat Rabies in Kenya

Following their recent agreement to tackle rabies, specifically in Machakos County, Boehringer Ingelheim and Vétérinaires sans Frontières Germany (VSF Germany) are enhancing their longstanding partnership. This collaboration features vaccination campaigns, community education initiatives, and teaching programs within schools. Boehringer Ingelheim

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EMA’s Human Medicine Committee Supports Approval of Acoramidis in Treating Transthyretin Amyloid Cardiomyopathy

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed acoramidis for market authorization in the European Union. Acoramidis is an orally consumed, selective small-molecule stabilizer of transthyretin (TTR). It targets adult individuals diagnosed with

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FDA Grants Breakthrough Status to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive MS

The U.S. Food and Drug Administration has awarded Breakthrough Therapy status to tolebrutinib for treating adult patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This decision stems from promising results in the HERCULES phase 3 trial, where tolebrutinib showed a

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EMA Advocates EU Marketing Authorisation for Emcitate by Rare Thyroid Therapeutics for Peripheral Thyrotoxicosis in AHDS Patients

The European Medicines Agency (EMA) has given its nod for marketing authorisation within the European Union (EU) for Emcitate (tiratricol), designed as an oral therapy targeting peripheral thyrotoxicosis, characterized by abnormal elevations of circulating thyroid hormones within individuals suffering from

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Merck Receives Favorable EU CHMP Verdict for Welireg in Certain VHL Tumors and Advanced RCC Patients After Prior Treatments

Merck, operating as MSD outside the US and Canada, revealed that the European Medicines Agency’s CHMP recommended conditionally approving Welireg (belzutifan), an oral inhibitor targeting hypoxia-inducible factor-2 alpha (HIF-2a), as a standalone treatment for: Adults with von Hippel-Lindau (VHL) disease

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Firm Measures Announced for Controlling Non-Prescription Drug Sales: Tamil Nadu’s New Drug Controller

M Sridhar, the incoming director of the Tamil Nadu Drug Control Administration (DCA), has announced plans to severely restrict the sale of habit-forming drugs and abortion pills without a prescription. Offenders will face stringent consequences. District-level awareness campaigns, headed by

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