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 agrees to an abridged Phase 3 clinical trial for Wockhardts WCK 5222, a superdrug antibiotic, according to the company.
Meridian Medical Technologies, a Pfizer company and Mylans manufacturing partner for EpiPen Auto-Injector, has expanded a recall of EpiPen (epinephrin...
FDA Review posts Federal Register notices for the week ending 3/31/2017.
FDA grants full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal grow...
FDA approves a Pfizer supplemental NDA for Ibrance (palbociclib) that converts the previous accelerated approval to a regular approval based on the re...