Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to re-pigment the skin of people with vitiligo.
AstraZeneca's antibody cocktail for COVID-19, now called Evusheld, has become the first drug in the class to be authorised for prevention of infection by the US FDA.
An FDA advisory committee has delivered a blow to Reata Pharma, after voting unanimously that the drugmaker's data on bardoxolone – a drug for kidney disease – did not show it is effective.
Merck & Co's strategy of pushing Keytruda earlier in the treatment pathway for cancers has secured anther victory, after the FDA approved the immunotherapy for adjuvant treatment of ski
An FDA advisory committee voted by 13 to 10 to recommend emergency-use authorisation for Merck & Co and Ridgeback's oral antiviral molnupiravir for mild-to-moderate COVID-19, saying it
BeyondSpring's hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company's lead drug plinabulin as a treatment for low wh
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