Food and Drug Administration (FDA)
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Seattle Genetics and Takeda show off the impressive survival data that prompted the FDA to give approval to Adcetris for this indication.
Novartis’ gene therapy treatment for spinal muscular atrophy could see approval as early as May of this year after the U.S. Food and Drug Administration granted AVXS-101, now dubbed Zolgensma, priority review.
A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.
GlaxoSmithKline announced it will acquire the Tesaro, based in Waltham, Mass., for $5.1 billion. For GSK, the deal marks an increased focus on oncology as it focuses on high growth areas.
Intellipharmaceutics International Inc. today announced that it has submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for its oxycodone hydrochloride immediate release (“IPCI006") tablets in the 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths.
Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
The FDA approved Xospata for adult AML patients who have a FLT3 mutation as detected by an FDA-approved test. Of the 19,000 people in the United States who are estimated to be diagnosed with AML this year, nearly 40 percent will have a FLT3 mutation.
The U.S. Food and Drug Administration (FDA) issued a warning letter to Faro Owiesy, a researcher and physician at the California-based Corona Doctors Medical Clinics, for violating a clinical hold. In addition, the agency warned Owiesy for giving an investigational drug to patients before an investigational new drug (IND) application was approved.
The U.S. Food and Drug Administration (FDA) gave the green light late Monday to Bayer oncology drug Vitrakvi, a first-of-its-kind TRK inhibitor, after late-stage clinical trial results showed a 75 percent overall response rate and 22 percent complete response rate across various solid tumors.
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