News Vinay Prasad returns to FDA In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.
News FDA makes it easier to set up US manufacturing sites The FDA has launched a programme to make it easier to set up manufacturing facilities in the US and reduce the country's reliance on imported drugs.
News Tidmarsh to stand in for Prasad's role at CBER Following Vinay Prasad's abrupt departure as CBER director, FDA has asked CDER head George Tidmarsh to take on both roles while a successor is sought.
News Vinay Prasad abruptly departs from the FDA The disruption at the FDA continues with the departure of CBER director Vinay Prasad, less than three months after taking on the role.
News FDA gives the go-ahead to restart Elevidys shipments Sarepta has restarted distribution of its Duchenne muscular dystrophy gene therapy Elevidys, but only for patients who can walk.
R&D Novel study designs for rare diseases Developing treatments for rare diseases poses many unique challenges that cannot be addressed by traditional study designs.
Oncology Getting predictive technologies to patients, with Concr Dr Irina Babina, CEO of oncology R&D platform Concr, discusses how current regulatory frameworks were built for static diagnostics.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.
