Food and Drug Administration (FDA)
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Days after receiving a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Nucala (mepolizumab) as an add-on COPD treatment, GlaxoSmithKline released data that showed the same medication was a superior treatment in severe eosinophilic asthma in patients with similar blood eosinophil counts.
Companies are taking a look at providing compounded versions of drugs. However, last week, new guidelines put forth by the U.S. FDA would hinder the notion of compounded drugs being sold due to price increases. The new guidelines will address the limits of compounded drugs that can be shipped across state lines.
Fibrocell Science, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma
Privately-held ITF Pharma snagged regulatory approval for Tiglutik, a liquid formulation of riluzole for the treatment of amyotrophic lateral sclerosis.
Eli Lilly and Company and its wholly-owned subsidiary Avid Radiopharmaceuticals, announced the successful Phase III trial of a Positron Emission Tomography (PET) imaging agent, flortaucipr F 18, in identifying tau in the brains of late-stage Alzheimer’s patients.
A patient advocacy organization is putting its weight behind an effort to urge the U.S. Food and Drug Administration to reconsider its recent decision to reject a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS). That rejection lead to a round of layoffs at Akcea.
Mylan plunked down $463 million for Novartis’ cystic fibrosis products, which includes the TOBI Podhaler and TOBI solution.
SpringWorks Therapeutics and BeiGene, Ltd. have teamed up to develop therapeutics that will target advanced solid tumors that contain RAS mutations, as well as other MAPK aberrations.
Although there is a general complaint about drug prices, which rocketed into the public domain during the 2016 U.S. presidential election, nothing particularly dramatic has been done about it.
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