FDA commissioner Robert Califf names agency chief scientist Namandj Bumpus as the replacement for retiring principal deputy commissioner Janet Woodcoc...
Novo Nordisk says it is seeking legal action against two compounding pharmacies it says are selling adulterated and misbranded drugs claiming to conta...
Based on new clinical study data, AbbVie says it will seek accelerated approval for telisotuzumab-vedotin in patients with c-Met protein overexpressio...
Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Products 21 CFR Parts 3 a...
UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.
FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.
FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsored by KemPharm, Apell...
