Two stakeholders give FDA recommendations on a draft guidance on assessing drug-drug interactions in therapeutic proteins.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...
FDA gives fast track designation to Surface Oncologys SRF 388 investigational liver cancer drug.