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August 20, 2021
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.
August 17, 2021
FDA has granted its first approval for an idiopathic hypersomnia treatment.
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
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.
August 06, 2021
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
August 05, 2021
EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.
August 04, 2021
Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment