ENDPOINTS NEWS2d
Ap­plied Ther­a­peu­tic­s' rare dis­ease drug gets a CRL
The FDA rejected Applied Therapeutics’ experimental treatment, govorestat, for a rare disease called classic galactosemia, ...
ENDPOINTS NEWS3d
Sat­suma's NDA fil­ing af­ter CMC woes; Hov­ione's Irish and US ex­pan­sion
FDA accepts Satsuma Pharmaceuticals' NDA resubmission for STS101 migraine drug. Hovione expands facilities in Ireland and New ...
ENDPOINTS NEWS3d
Bris­tol My­ers sues the fed­er­al gov­ern­ment over 340B, fol­low­ing oth­er drug­mak­ers
Bristol Myers Squibb is the latest pharma company to sue the federal government over its rejection of a proposed new model ...
ENDPOINTS NEWS3d
Nor­bert Bischof­berg­er's time as Kro­nos CEO ends as biotech seeks new life
Kronos Bio announces 83% workforce reduction and CEO Norbert Bischofberger's departure, with CFO Deborah Knobelman taking ...
ENDPOINTS NEWS3d
Out­look's shares crash as wet AMD drug flunks Phase 3 test
Outlook Therapeutics' ONS-5010 (bevacizumab) failed to meet its primary endpoint in a Phase 3 trial against Roche's Lucentis ...
ENDPOINTS NEWS3d
Idor­sia eyes lay­offs, tees up Tryvio li­cens­ing deal to ex­tend cash run­way
Idorsia announces 270 potential layoffs, primarily affecting R&D and headquarters support functions. The company is ...
ENDPOINTS NEWS5d
Trump team asked Warp Speed leader to head NIH, may seek more tra­di­tion­al pick for role
The transition team for President-elect Donald Trump was still searching for its next National Institutes of Health director ...
ENDPOINTS NEWS3d
Ad­vanz Phar­ma faces re­vo­ca­tion of Eu­ro­pean au­tho­riza­tion for liv­er dis­ease drug Ocali­va
Advanz Pharma's liver treatment Ocaliva lost EU marketing authorization following a court decision. The drug, used for ...
ENDPOINTS NEWS4d
The Biden ad­min­is­tra­tion wants Medicare and Med­ic­aid to cov­er GLP-1s. Will the Trump White House al­low it?
The Biden administration proposed a new rule Tuesday that would expand Medicare and Medicaid coverage of popular obesity ...
ENDPOINTS NEWS4d
Soleno’s rare pe­di­atric dis­ease drug faces PDU­FA de­lay by three months
FDA extends review of Soleno Therapeutics' diazoxide choline extended-release tablets for Prader-Willi syndrome by three ...
ENDPOINTS NEWS4d
Why Mor­gan Health is back­ing an autism care com­pa­ny
JP Morgan's Morgan Health co-led an $80 million investment in Cortica, an autism care provider, marking its seventh ...
ENDPOINTS NEWS4d
Ax­some moves to­ward NDA fil­ing for nar­colep­sy drug fol­low­ing pos­i­tive Phase 3 da­ta
Axsome Therapeutics’ narcolepsy drug AXS-12 hit the primary endpoint in its Phase 3 ENCORE trial, showing a statistically ...