Lupin Pharmaceuticals Inc., a wholly-owned subsidiary of Lupin is voluntarily recalling two lots of Tydemy to the patient level due to out-of-specification (OOS) test results at the 12-month stability time point
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Glenmark Pharmaceuticals, an Indian pharmaceutical company has received final approval from the United States Food and Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza1 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB
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A U.S. judge on Friday shot down Johnson & Johnson's second attempt to resolve tens of thousands of lawsuits over its talc products in bankruptcy, imperiling a proposed USD 8.9 billion settlement that would stop new lawsuits from being filed
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The company said that at the end of the inspection, USFDA issued a ‘Form 483’ with 3 observations. Calling the observations procedural in nature the company said it will respond to USFDA within given time
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To commence the trial, getting the sanction for prosecution is a requisite before proceeding a case against a government servant under the Prevention of Corruption Act
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Dolutegravir Lamivudine is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. Whereas Tenofovir alafenamide is a medication for the treatment of chronic hepatitis B virus in adults with compensated liver disease
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Daiichi Sankyo said the U.S. health regulator has approved its drug for treating newly diagnosed patients suffering from an aggressive type of blood cancer, pitting the treatment against those from rivals Novartis and Astellas
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The pharma major stated that the Unit has now received Establishment Inspection Report classifying the facility as "Voluntary action indicated" (VAI)
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