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The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.
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The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards
Neuronix Ltd. announced that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Committee met on March 21 to consider data and receive public comment about the neuroAD™ Therapy System, a non-invasive medical device for the treatment of mild-to-moderate Alzheimer's disease.
A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.
Getting effective treatments for diseases and conditions to people as quickly as possible while guaranteeing their safety and efficacy, as well as protecting the safety of trial subjects, has always been a delicate balancing act for the U.S. Food and Drug Administration (FDA), the federal agency responsible for the safety of pharmaceuticals and medical devices, among other things.
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Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform
The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.
Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today issued a statement on Biogen Inc.'s decision to discontinue its global Phase 3 trials of aducanunab in Alzheimer's disease.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the Food and Drug Administration.
Viome, a company transforming health through personalized nutrition based on individual biology, today announces it will collaborate with precision health leader, Helomics, to study the link between the gut microbiome and ovarian cancer.
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.
Label Now Includes New Data on Use of AVYCAZ for Treatment of cUTI and cIAI in Pediatric Patients 3 Months of Age and Older
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth.
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement last week on the importance of naming biological medicines that will benefit by having a lower cost to patients.
The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally.
The U.S. Food and Drug Administration allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning.
The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart’s left atrium that can cause heart failure symptoms such as shortness of breath, fatigue and swelling in the legs.