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 notice: In separate rulemakings, FDA proposes to classify into Class 3 certain types of wound dressings and liquid wound washes conta...
FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or third-line treatment ...
AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.
