Food and Drug Administration (FDA)
NEWS
As we end October and head into November, the Food and Drug Administration (FDA) continues its work. This upcoming week has several PDUFA action dates for drug applications. Here’s a look.
In the company’s FDA Law Blog, attorneys Deborah L. Livornese, JP Ellison and Josephine M. Torrente outlined problems with the FDA’s complete response letter (CRL) and what should be done about it.
The U.S. Food and Drug Administration (FDA) is eying the spring of 2019 to finalize its biopharmaceutical classification system-based biowaivers guidelines. On Thursday, the regulatory agency released the draft guidance for public consultation.
In a survey of more than 8,000 people in the biotech and pharma industry for Science, Regeneron Pharmaceuticals, topped the list.
Regeneron Pharmaceuticals’ Eylea (aflibercept) showed strongly positive data in a Phase III trial in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR). The trial met its 52-week primary endpoint and key secondary endpoints.
Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The new medication has a novel mechanism of action that, Roche said, inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate.
Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
A prostate cancer drug jointly developed by healthcare giant Bayer and Finland-based Orion can slow the spread of the disease, according to late-stage study results announced early Wednesday.
The FDA, as well as other government agencies, have expressed alarm at the rate of opioid-related overdoses in the United States – an issue that has become an epidemic across the heartland.
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