The international GMP approval will enable the company to expand its product portfolio globally with more marketing authorisations not only from Ukraine, which happens to be one of the largest pharmaceutical markets in the Common Wealth of Independent States
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Concept Medical, an innovative medical devices company, has received its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (USFDA) to treat Superficial Femoral Arteries (SFA), the company informed in a press statement
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The U.S. Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals Inc's drug for a broad treatment of heart failure, including in adult patients with type 2 diabetes, the company said on Friday. Shares of the company rose 13 per cent in extended trading
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India will make tests mandatory for cough syrups before they are exported, a government notice showed on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan
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Rakuten Medical, a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox platform, stated that the company has been granted permission from the Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial
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On Friday, Aurobindo Pharma's Unit XIV, an API Non-antibiotic Manufacturing facility situated at Paravada Industrial Area, Anakapalli District got inspected by the United States Food and Drug Administration (USFDA) from 15th May to 19th May 2023, the company stated in an exchange filing
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The panel of outside experts voted 15-to-1 against the approval for obeticholic acid (OCA) based on surrogate biomarker data suggesting it was likely to benefit patients with NASH (non-alcoholic steatohepatitis) and fibrosis, or scarring, of the liver.
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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials. The drug is generic equivalent of US Reference Listed Drug Akovaz Injection
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