Jemperli gets FDA priority review for expanded indication in endometrial cancer
The sBLA submission is supported by data from Part 1 of RUBY Phase 3 trial which successfully met…
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25 Apr 24
The sBLA submission is supported by data from Part 1 of RUBY Phase 3 trial which successfully met…
25 Apr 24
The approval was based on results from three controlled clinical trials of females aged 18 and above in…
25 Apr 24
The approval was based on the results from the Phase 3 PROTECT study which reached its primary endpoint…
24 Apr 24
The deal includes EP262, a first-in-class, potent, highly selective, once-daily small molecule MRGPRX2 antagonist, and EP547, a first-in-class…
24 Apr 24
The approval was based on the results from the Phase 3 EMBARK trial which met its primary endpoint…
24 Apr 24
The approval is based on results from the ALPHA Phase 3 trial in which Voydeya met the primary…
24 Apr 24
The designation was requested based on the potential for MC-1 to address an unmet medical need for PNPO…
23 Apr 24
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and…
22 Apr 24
The approval was based on results from Phase 3 ALINA study in which Alecensa lowered the risk of…
19 Apr 24
The regulator has authorised Entyvio as a maintenance drug for individuals with moderately to highly active Crohn's disease…