Eli Lilly has put a clinical trial of its COVID-19 antibody therapy on hold after FDA inspectors found serious quality control problems at the plant, according to press reports.
The FDA may have been blocked from issuing stricter guidelines for emergency approval of COVID-19 vaccines by the Trump administration, but it has still managed to make its new approach pub
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
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
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.