Theravance Biopharma and Mylan NV file an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist as a once-daily, nebuliz...
The American Hospital Association urges FDA to intervene and expedite the resolution of the worsening shortages of small-volume parenteral solutions t...
FDA clears a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test intended to detect bl...
FDA approves an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen injector, indicated for...
FDA approves an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia.
FDA Review posts the Federal Register notices for the week ending 11/10/2017.
FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating...
FDA approves a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection ...