Amy­lyx shares rout­ed on skep­ti­cal ad­comm docs — but did the FDA leave an open door on un­met ALS need?

4 years ago
R&D
FDA+

As Gilead’s stock price gets blitzed af­ter a se­ries of prat­falls, why is Dan O’Day get­ting a small raise?

4 years ago
People
Bioregnum

UCB lands FDA ap­proval in newest in­di­ca­tion for new­ly-ac­quired Zo­genix epilep­sy drug

4 years ago
Pharma
FDA+

Spe­cial­ty phar­ma play­er snaps up Aca­cia and its 2 drugs for a handy $100M

4 years ago
Deals

Ver­tex strikes agree­ment with Aus­tralia for cys­tic fi­bro­sis pill, end­ing high-pro­file stand­off

4 years ago
Pharma

Paul Hud­son's rare dis­ease piv­ot takes a small step for­ward, as Nie­mann-Pick drug wins Japan ap­proval

4 years ago
FDA+

US halts use of GSK/Vir mon­o­clon­al in 8 states as FDA says it can't de­feat new Omi­cron sub­vari­ant

4 years ago
Coronavirus

ALS drug sets the stage for fresh FDA de­bate; Im­plo­sions every­where you look; Big names turn up at biotechs; and more

4 years ago
Weekly

Mer­ck fi­nal­ly free from frac­ture law­suits over Fos­amax la­bel

4 years ago
Pharma
Law

Can­cer drug prices rise in the US de­spite an in­creas­ing­ly com­pet­i­tive mar­ket — re­port

4 years ago
Pharma

EMA OKs two new drugs — J&J's BC­MA CAR-T for mul­ti­ple myelo­ma, As­traZeneca's Evusheld — plus 5 la­bel ex­pan­sions

4 years ago
Pharma
FDA+

Mo­bile apps for IBS? In­de­gene teams with metaMe to launch 'gut-di­rect­ed hyp­nother­a­py' dig­i­tal ther­a­peu­tic

4 years ago
Pharma
Marketing

Ab­b­Vie, En­do hit with sub­poe­nas amid Texas AG's at­tempts to lim­it med­ical care for trans youth

4 years ago
Pharma
Law

'March-in' bat­tles heat up as non­prof­its pe­ti­tion HHS on 6 drugs as ear­li­er pe­ti­tion awaits de­ci­sion

4 years ago
Pharma

Big Phar­ma has skirt­ed long Covid, but a pipeline of small biotechs is test­ing treat­ments for lin­ger­ing symp­toms

4 years ago
R&D
Coronavirus

A biotech de­vel­op­ing a syn­thet­ic bi­ol­o­gy Covid-19 vac­cine comes up short in first da­ta read­out — and in­vestors are ...

4 years ago
R&D
Coronavirus

An­oth­er RA-backed biotech hits Nas­daq as pub­lic mar­ket stirs again af­ter a bruis­ing first quar­ter

4 years ago
Financing

Bris­tol My­er­s' hope for a third Re­blozyl OK de­layed by three months

4 years ago
R&D
Pharma

Intar­cia may fi­nal­ly get its post-CRL re­view, al­though FDA points to Covid and an­oth­er hear­ing as tak­ing pri­or­i­ty

4 years ago
FDA+

No more ac­cel­er­at­ed ap­provals for PI3K? Biotech cites FDA's 'cur­rent po­si­tion' as it warns of ma­jor de­lay

4 years ago
FDA+

Roger Perl­mut­ter lures Roy Baynes away from Mer­ck; Now, Voy­ager: Al San­drock be­comes a CEO af­ter break from Bio­gen

4 years ago
Peer Review

Jim Al­li­son launch­es new in­sti­tute aimed at speed­ing drug de­vel­op­ment and rais­ing 'sur­vival curve for all can­cer­s'

4 years ago
R&D

Sun Phar­ma shelling out $485M to set­tle US an­titrust case against gener­ics gi­ant

4 years ago
Pharma
Law

With com­peti­tors cir­cling, Vi­iV wins an­oth­er la­bel up­date for long-act­ing HIV in­jectable Cabe­nu­va

4 years ago
Pharma
FDA+
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