Eu­ro­pean reg­u­la­tors for­ti­fy sin­gle-arm tri­al ad­vice, but un­der­score pref­er­ence for place­bo-con­trolled de­signs

8 months ago
FDA+

FDA tells on­col­o­gy com­pa­nies how to run mul­ti-re­gion­al can­cer tri­als with a US ap­proval in mind

8 months ago
R&D
FDA+

FDA ap­proves Lil­ly's eczema drug Ebglyss for mod­er­ate-to-se­vere dis­ease

8 months ago
Pharma
FDA+

Boehringer plans NDA fil­ing for pul­monary fi­bro­sis drug fol­low­ing Phase 3 da­ta

8 months ago
R&D

Roche out­lines com­mer­cial man­u­fac­tur­ing strat­e­gy for GLP-1/GIP as­sets 

8 months ago
Pharma
Manufacturing

BioN­Tech rolls out Phase 2 lung can­cer da­ta as VEGF bis­pecifics take cen­ter stage

8 months ago
R&D

Nu­va­len­t's $350M of­fer­ing; FDA lifts par­tial hold on Zen­tal­is drug

8 months ago
News Briefing

Ochre Bio CEO Jack O’Meara steps down, out­lines plans for next start­up

8 months ago
People
Startups

Ex-Kite lead­ers step in at Kyver­na as CEO ex­its af­ter land­ing year's sec­ond-biggest IPO

8 months ago
People
Cell/Gene Tx

Im­mat­ics los­es Bris­tol My­er­s' sup­port on Phase 1 bis­pe­cif­ic T cell en­gager

8 months ago
Deals
R&D

Phys­i­cal ther­a­py start­up Sword Health shifts to a nov­el way of get­ting paid

8 months ago
Health Tech

Mer­ck­'s Eli­av Barr on sub­cu­ta­neous Keytru­da, Sum­mit and deal shop­ping

8 months ago
People
R&D

Ex­elix­is’ drug staves off neu­roen­docrine tu­mor pro­gres­sion in broad swath of pa­tients

8 months ago
R&D

Biotech IPO mar­ket still in flux fol­low­ing flashy Fri­day triple­head­er

8 months ago
Financing
Startups

In sur­prise, study sug­gests Covid mR­NA vac­cines may boost can­cer im­munother­a­py ef­fi­ca­cy

8 months ago
R&D
Pharma

Keytru­da and Lenvi­ma still have an­oth­er hill to climb fol­low­ing lat­est da­ta drop

8 months ago
R&D
Pharma

As­traZeneca un­veils what it calls ‘prac­tice-chang­ing’ Imfinzi da­ta in blad­der can­cer

8 months ago
R&D
Pharma

Scor­pi­on de­tails ear­ly da­ta on tar­get­ed breast can­cer drug as it seeks to chal­lenge No­var­tis, Roche

8 months ago
R&D

In­cyte gears up to face FDA once again with more Zynyz da­ta in rare anal can­cer

8 months ago
R&D
Pharma

Pfiz­er tees up Phase 3 test in weight man­age­ment — but in an un­ex­pect­ed area

8 months ago
R&D

Up­dat­ed: Bris­tol My­ers touts LAG-3 strat­e­gy in lung can­cer, but da­ta caveats damp­en ex­cite­ment

8 months ago
R&D

House pass­es Biose­cure Act; Mod­er­na out­lines more cost cuts; What's hap­pen­ing at #ES­MO24; and more

8 months ago
Weekly

Nu­va­tion Bio to head to FDA with pooled ROS1-pos­i­tive lung can­cer da­ta

8 months ago
R&D

Up­dat­ed: GSK, iTeos re­ju­ve­nate strug­gling TIG­IT space with pos­i­tive Phase 2 Jem­per­li com­bo da­ta in lung can­cer

8 months ago
R&D
Pharma
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