The latest drug development news and highlights from our FDA Performance Tracker.
FDA's Center for Drug Evaluation and Research reached one dozen novel agent approvals this year after a shower of approvals in the last week – Intercept Pharmaceuticals Inc.'s Ocaliva, Biogen Inc. and AbbVie Inc.'s Zinbryta and two PET imaging agents.
Teva Pharmaceutical Industries Ltd.'s Huntington's chorea drug stumbled, receiving a complete response letter, but the company aims to resubmit...
Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
