FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or third-line treatment ...
FDA says it is evaluating possible safety issues with some plastic syringes manufactured by several firms in China.
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.
