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August 18, 2021
Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.
August 17, 2021
FDA has granted its first approval for an idiopathic hypersomnia treatment.
August 16, 2021
FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.
August 13, 2021
The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.
August 12, 2021
FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
August 11, 2021
The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.
August 09, 2021
Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.
FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.