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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and various endpoints for new drugs or biologics intended to treat acute myeloid leukemia (AML), according to a new draft guidance.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
The FDA has finally put muscle behind its authority to fine flouters of the ClinicalTrials.gov reporting requirements, issuing a final guidance last week that confirms penalties of up to $10,000 per violation. Read More
The EU’s orphan drug regulations are not adequately supporting the development of medicines for rare diseases, according to a new report conducted on behalf of the European Commission. Read More