A decision from the FDA is due by 28 September.
Sanofi’s multiple sclerosis candidate tolebrutinib is in line for a potential US approval in the autumn after the Food and Drug Administration agreed to a speedy review of the oral Bruton’s tyrosine kinase (BTK) inhibitor.
The regulatory agency is evaluating tolebrutinib under priority review for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and...
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Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.
The biotech announced positive results in the PIK3CA wild-type population in second-line HR+/HER2- breast cancer for its PAM inhibitor.
The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.
Comes Days After PDUFA Pushback For GSK's Blenrep.
With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.
The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.
Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.
