FDA approves an Audentes Therapeutics IND for AT132, the companys gene therapy product candidate to treat X-Linked Myotubular Myopathy.
FDA grants an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system.
FDA tells Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the companys BLA for Heplisav-B [...
FDA clears an ETS Wound Care 510(k) for the Mirragen Advanced Wound Matrix for use in treating acute and chronic wounds.
FDA approves a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating chorea associated with Huntingtons disease.
FDA Review posts Federal Register notices for the week ending 3/31/2017.
Alliance for a Stronger FDA says the agency could win or lose $40 million in the current fiscal year continuing resolution depending on whether Congre...
FDA grants full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal grow...