FDA

News

EMA review of AZ’s COVID-19 vaccine imminent; report

The EU regulator is poised to start a review of AstraZeneca and Oxford University’s COVID-19 vaccine, but the FDA is widening its investigation into the shot’s safety, according to reports

News

CTI wins over FDA to claim early review of myelofibrosis dru...

Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused b

News

FDA fast-tracks AbbVie's spinal injury drug

The FDA has fast tracked development of AbbVie’s potential spinal injury drug, elezanumab, a process that will be aided by digital analysis.

News

FDA slams brakes on Inovio's final-stage COVID-19 vaccine tr...

Inovio Pharma’s plan to start pivotal testing of its COVID-19 vaccine has been delayed by FDA requests for more information, sending its shares into a swift decline.

News

FDA launches Digital Health Center of Excellence

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and

News

"Tokyo, Japan - May 11, 2012: Pfizer building on May 11, 2012 in Tokyo. Pfizer is one of largest pharmaceutical companies worldwide with tremendous revenue $67.4 bn USD for 2011. It exists since 1849."

Scientists urge Pfizer to delay COVID-19 vaccine filing

A group of leading scientists have urged Pfizer to wait until at least late November before asking for the FDA to authorise its potential COVID-19 vaccine, to double-check its safety.

EMA review of AZ’s COVID-19 vaccine imminent; report

CTI wins over FDA to claim early review of myelofibrosis dru...

FDA fast-tracks AbbVie's spinal injury drug

FDA slams brakes on Inovio's final-stage COVID-19 vaccine tr...

FDA launches Digital Health Center of Excellence

Scientists urge Pfizer to delay COVID-19 vaccine filing

Third Rock in $2bn drug-hunting pact with China's Funnel

Securing your ROI: Turning post-acquisition integration into...

FDA

Editor's Picks