Food And Drug Administration

Fda Approves Epizyme's Sarcoma Drug Tazverik

Epizyme (NASDAQ: EPZM) secured an accelerated approval from the Food and Drug Administration for its sarcoma drug Tazverik. The drug was approved specifically for patients with metastatic or locally advanced epithelioid sarcoma who aren't eligible...
Related topics: Nasdaq

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Fda Warns Hospitals About Security Flaws In Some Ge Medical Equipment

Some GE medical equipment have vulnerabilities that make them easy to tamper with, according to the FDA. The agency has warned hospitals and healthcare providers that a third-party cybersecurity firm has identified flaws in certain GE Healthcare...

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Overnight Health Care: Who Declines To Declare Chinese Virus A Global Emergency | Insurers To Help...

Welcome to Thursday's Overnight Health Care.The novel coronavirus outbreak is not a public health emergency yet, Blue Cross wants to lower drug prices, and a House Democrat wants FDA to step up oversight on menthol e-cigarettes.We'll start with...
Related topics: Virus, Virology

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Fewer Than Half Of Clinical Trials Comply With Reporting Laws

THURSDAY, Jan. 23, 2020 -- Compliance with the U.S. Food and Drug Administration Amendments Act of 2007 is low, with only 40.9 percent of trials reporting results within one year, according to a study published online Jan. 17 in The...
Related topics: Clinical Trials, Medical Research, The Lancet

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Horizon Therapeutics Gets Fda Approval For Eye Drug

After market close on Tuesday, Irish drug company Horizon Therapeutics (NASDAQ: HZNP) received a nice surprise from the Food and Drug Administration (FDA). The company's drug Tepezza was approved earlier than expected. This is the first therapy...
Related topics: Nasdaq

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Peter Thiel On The Funding Of Science

At a keynote address at the Precision Medicine World Conference, Thiel argued for enabling riskier research grant-making via institutions such as the NIH, as well as abandoning the scientific staple of the double-blind trial and encouraging the U.S....
Related topics: Medical Research

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More Evidence Of Sunscreen Systemic Absorption

]]>(MedPage Today) -- Six ingredients commonly found in sunscreens had systemic absorption levels that exceeded FDA recommendations, according to a clinical evaluation of four sunscreen formulations. Mean plasma concentrations of avobenzone...

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Fda Oks First Drug For Thyroid Eye Disease

]]>(MedPage Today) -- The FDA approved teprotumumab (Tepezza) on Tuesday for adults with thyroid eye disease, making it the only non-surgical, FDA-approved treatment for this potentially blinding condition. Teprotumumab is a fully human...

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Fda Documents Show Safety Concerns Over A Sarepta Drug

The Food and Drug Administration released a set of documents on Wednesday that questioned the safety of a newly approved drug from Sarepta Therapeutics (NASDAQ: SRPT). The drug, Vyondys 53 (golodirsen), is a treatment for Duchenne muscular dystrophy...
Related topics: Sarepta, Nasdaq, Duchenne Muscular Dystrophy, Muscular Dystrophy

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Most Clinical Trials Still Don't Report Results

Fewer than half of trials in an analysis met the FDA's 1-year window for reporting results. Unreported results can distort evidence, erode participants' trust, and waste resources. Medscape Medical News
Related topics: Clinical Trials

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What Do You Think Of Faster Fda Approvals?

A new analysis indicates the US Food and Drug Administration is increasingly accepting less data for drug approvals and shortening its reviews. Medscape Reader Polls
Related topics: Polls

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Fda Approves First Treatment For Thyroid Eye Disease

The monoclonal antibody teprotumumab reduces proptosis and related eye problems in patients with thyroid-associated ophthalmopathy. FDA Approvals

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Fluoroquinolones, Cancer Drugs On New Fda Watch List

Eight fluoroquinolones made the list, with potential signs of risk for mitral and aortic regurgitation. Medscape Medical News
Related topics: Cancer, Oncology

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Astrazeneca And Merck Get An Fda Priority Review For Lynparza In Prostate Cancer

AstraZeneca (NYSE: AZN) and Merck (NYSE: MRK) continue their quest to gain additional approvals for their blockbuster cancer drug Lynparza. The duo submitted a new application to the Food and Drug Administration for the drug as a treatment for...
Related topics: Astrazeneca, Merck & Co, Prostate Cancer, Cancer, Oncology

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2 Reasons To Be Optimistic About Biogen’s Alzheimer’s Drug

Biogen (NASDAQ: BIIB) shocked investors last year when it said it would submit its investigational Alzheimer's drug to the Food and Drug Administration for approval -- months after halting studies that showed the drug didn't work.The biotech company...
Related topics: Alzheimer's Disease, Nasdaq

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Fda Puts Glaxosmithkline's Blood Cancer Drug In The Fast Lane

GlaxoSmithKline's (NYSE: GSK) experimental new cancer drug, belantamab mafodotin, will receive a priority review from the U.S. Food and Drug Administration. The agency's recent decision means belantamab will probably become the first of several...
Related topics: GlaxoSmithKline, Cancer, Oncology

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Astrazeneca Announces Positive Fda Updates On Cancer Drugs

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock...
Related topics: Astrazeneca, Cancer, Oncology, Medical Research

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Ozempic's New Heart Indication; Pesticides Shave Kids' Iq Points

]]>(MedPage Today) -- The FDA expanded the label of Novo Nordisk's injectable glucagon-like peptide-1 (GLP-1) analogue semaglutide (Ozempic), which now carries an indication for major adverse cardiovascular event reduction in adults with type 2...
Related topics: IQ (Intelligence Quotient), Type 1 Diabetes, Cardiology, Type 2 Diabetes, Diabetes

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Congress And The Fda May Square Off Over Cbd

To say that the marijuana industry had a bad 2019 wouldn't do justice to just how awful things were. Despite seeming to be on the cusp of profitability, cannabis stocks throughout North America wound up being clobbered by a variety of issues, with a...

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Fda Warns Of Surgical Gowns That May Not Be Sterile

FRIDAY, Jan. 17, 2020 -- Certain surgical gowns and surgical packs made by Cardinal Health may not be sterile and should not be used, the U.S. Food and Drug Administration said Thursday. On Jan. 11 and Jan. 15, 2020, the medical device maker...
Related topics: Cardinal Health

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