Food and Drug Administration (FDA)
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New data unveiled by Windtree Therapeutics shows significant promise in heart failure patients who have deteriorated into cardiogenic shock.
Axsome Therapeutics received good news regarding its NDA for AXS-05, a treatment for depression, and Aytu BioScience received Fast Track designation for its VEDS treatment.
Finch Therapeutics has slashed its headcount by 20% in order to free funds to focus its resources on its programs in recurrent C. difficile infection and autism spectrum disorder
Ocugen has amended its co-development, supply and commercialization deal with Bharat to include Mexico and now holds the rights for the Covaxin vaccine for all of North America.
The charges come from several in-process research and development projects acquired outside of a business combination.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
McKinsey & Company is under fire for allegedly allowing its employees to work simultaneously for big pharma companies and serve as consultants for the U.S. Food and Drug Administration.
The U.S.Food and Drug Administration has granted Emergency Use Authorization to a breathalyzer that can detect COVID-19 within three minutes.
Regeneron announced that the U.S. FDA has extended its review of the BLA for monoclonal antibody REGEN-COV, which treats COVID-19.
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