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In a surprise U-turn, the FDA on Sunday authorized the emergency use of convalescent plasma for treating COVID-19, following accusations by President Trump that the agency was holding off on issuing an Emergency Use Authorization (EUA) for political reasons. Read More
As of Friday evening, the pharma industry had still not put forward a price-cutting strategy that could sway the president into discarding a drug pricing executive order he has threatened to enforce. Read More
President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients. Read More
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Read More
The FDA has released a question-and-answer guidance to clarify its policies on inspections, pending drug applications and changes in manufacturing facilities for approved drug products during the COVID-19 pandemic. Read More
The Department of Justice has made another move against a drugmaker in its investigation of an alleged industry-wide kickback scheme, accusing Teva Pharmaceuticals of funneling kickbacks for its multiple sclerosis drug Copaxone (glatiramer acetate) through charitable foundations. Read More
Gilead Sciences has received a complete response letter (CRL) from the FDA for its potential blockbuster rheumatoid arthritis treatment filgotinib, calling for more data from ongoing studies. Read More
BioMarin Pharmaceutical announced that the FDA has declined to approve its investigational gene therapy for severe hemophilia A, valoctocogene roxaparvovec, and the agency wants to see two years of follow-up data from a phase 3 study. Read More
The FDA is willing to consider a range of clinical trial designs and various endpoints for new drugs or biologics intended to treat acute myeloid leukemia (AML), according to a new draft guidance. Read More