The FDA has approved Strides Pharma Global, Singapore's generic theophylline extended-release tablets, 300 mg and 450 mg.The product is identical in bioavailability and therapeutic effects to the Reference Listed Drug (RLD), THEO-DUR, from...
BlueRock Therapeutics LP, a company developing cell therapy in clinical stage and a subsidiary of Bayer AG, announced the FDA's approval of its IND application for OpCT-001, a treatment for primary photoreceptor diseases. BlueRock Therapeutics LP...
The FDA broadened the uses of Insulet SmartAdjust, a technology for diabetes management, to include type 2 diabetes in adults over 18 years old, in addition to type 1 diabetes in individuals aged two and older. Software that automatically adjusts...
Granules India's subsidiary, Granules Pharmaceuticals Inc, has been granted approval by the US health regulator for a generic Glycopyrrolate oral solution meant for pediatric patients with neurological conditions linked to drooling. Granules India...
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