FDA+ channel feed

Com­pound­ing as­so­ci­a­tion to ask for clar­i­ty around tirzepatide's short­age sta­tus

6 months ago
Pharma

FDA lead­ers kick off rare dis­ease hub to in­crease cross-cen­ter col­lab­o­ra­tion

6 months ago

FDA places hold on No­vavax's Covid-flu and stand­alone in­fluen­za vac­cines

6 months ago
R&D

No­var­tis used a PRV to speed Kisqal­i's lat­est in­di­ca­tion, FDA says

6 months ago

Pfiz­er gets an FDA win in he­mo­phil­ia af­ter a rough week

7 months ago
R&D
Pharma

Stealth Bio­Ther­a­peu­tics CEO dis­cuss­es sur­prise ad­comm sup­port for ul­tra-rare dis­ease drug

7 months ago
People

Ex­clu­sive: PhRMA at­tacks fed­er­al gov­ern­men­t's re­sponse to re­bate mod­el for 340B

7 months ago
Pharma

FDA ad­comm sup­ports first po­ten­tial drug for ul­tra-rare, fa­tal Barth syn­drome

7 months ago

Up­dat­ed: FDA ap­proves Roche's new treat­ment for sub­set of breast can­cer pa­tients

7 months ago
Pharma

Sev­en pa­tients di­ag­nosed with blood can­cer af­ter Skysona treat­ment, new da­ta show

7 months ago
R&D

CMS looks to $2 out-of-pock­et cap for some com­mon­ly used gener­ic drugs

7 months ago
Pharma

Ex­clu­sive Q&A: FDA's prin­ci­pal deputy com­mis­sion­er on tak­ing over for Califf, ad­comms, ac­cel­er­at­ed ap­provals and more

7 months ago
People
Law

Cov­er­ing obe­si­ty drugs could cost Medicare $35B by 2034, CBO says

7 months ago

Zealand Phar­ma hit with sec­ond CRL for glucagon re­cep­tor ag­o­nist

7 months ago
Pharma
Manufacturing

FDA again rais­es doubts on Stealth's ul­tra-rare dis­ease drug ahead of ad­comm

7 months ago

Many drug price pro­pos­als from can­di­dates and Con­gress won't have much ef­fect, analy­sis finds

7 months ago
Law

BAR­DA doles out $72M to Sanofi, GSK and CSL for bird flu vac­cine sup­ply

7 months ago
Pharma

EMA re­views hair loss prod­ucts fol­low­ing con­cerns about sui­ci­dal thoughts

7 months ago
Pharma

UK gov­ern­ment pro­pos­es phased roll­out of Eli Lil­ly's weight loss drug

7 months ago
Pharma

FDA's drug cen­ter launch­es new co­or­di­nat­ing body for mod­el­ing and sim­u­la­tion

7 months ago

Op­di­vo gets FDA ap­proval for use around lung can­cer surgery, fol­low­ing Keytru­da and Imfinzi

7 months ago
R&D

As­traZeneca, Ab­b­Vie, PhRMA lose court bat­tle over Louisiana 340B law

7 months ago
Pharma
Law

EMA looks to make its drug ap­proval process­es more ef­fi­cient

7 months ago

Up­dat­ed: Sen­a­tors ques­tion FDA and FTC over patent and PBM re­forms

7 months ago
Law
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