Beyond Air says it submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn.
Two stakeholders give FDA recommendations on a draft guidance on assessing drug-drug interactions in therapeutic proteins.
Federal Register notice: FDA seeks comments on an information collection extension for Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis...
Federal Register notice: FDA has published a list of seven information collections that have been approved by OMB.
Pfizer says its investigational atopic dermatitis drug abrocitinib met its primary and key secondary endpoints in the Phase 3 JADE REGIMEN trial.
A U.S. Senate Appropriations Committee-released bill for fiscal year 2021 proposes $3.21 billion in discretionary funding for FDA, which is about $50 ...
FDA gives de novo marketing authorization to the NightWare therapeutic platform to interrupt PTSD-associated nightmares.
FDA approves a Sebela Pharmaceuticals NDA for Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, indicated for colonoscopy pre...