Tag: FDA

Novartis aquired FDA approval for lung cancer drug

Novartis announced the US Food and Drug Administration (FDA) approved the expanded use of Zykadia (ceritinib)

Bayer obtained FDA priority review for cancer drug

German drugmaker Bayer won the U.S. Food and Drug Administration's priority review status for an experimental drug for a difficult to treat type of blood cancer, bolstering its development pipeline.

FDA inspected Strides Shasun plant in India

Indian pharmaceutical company Strides Shasun said the US health regulator has not made any observations after inspection of its manufacturing facility in Puducherry. The company’s active pharmaceut...

FDA approved new leukemia drug

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The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation cal...

Samsung Bioepis received its first approvement by FDA

Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS (infliximab-abda), a biosimilar referencing Remicade (infliximab), across all eligible indic...

FDA approved Glenmark’s generic drug

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Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (FDA) for fenofibrate capsules USP, 67 mg, 134 mg and 200 mg, the generic version of Tricor...

The New England Journal of Medicine compared FDA and EMA

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The New England Journal of Medicine compared review times for new therapeutic agents that were approved by the The Food and Drug Administration (FDA) or The European Medicines Agency (EMA) between 201...

FDA approved Teva’s neurological drug

The FDA has approved Teva’s Huntington’s Disease drug, the first new treatment for the neurological disease in almost a decade. Austedo (deutetrabenazine) tablets for the treatment of chorea associate...

GSK recalled asthma drug in U.S. because of a defect

GSK is voluntarily recalling more than 593,000 Ventolin asthma inhalers from U.S. hospitals, pharmacies, retailers and wholesalers due to a defect that may cause them to deliver fewer doses of the med...

U.S. prohibited Indian pharmaceutical factory

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U.S. health regulators have banned a drug production site in India belonging to Divi's Laboratories Ltd due to manufacturing violations, sending the company's shares down to a near three-year low. ...

FDA warned API manufacturers from China and India

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The US Food and Drug Administration (FDA) released two warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceutica...