US FDA Nods BlueRock's IND Application For iPSC-derived Cell Therapy

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...

US FDA Nods SmartAdjust technology for Individuals with type 2 Diabetes

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 Receives USFDA Nod for Generic Glycopyrrolate Oral Solution

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...