FDA+ channel feed

Lykos is op­ti­mistic about MD­MA treat­ment af­ter meet­ing with FDA

7 months ago
R&D
Pharma

FDA won't take ac­tion against GLP-1 com­pounders as it re­thinks tirzepatide short­age

7 months ago
Law
Health Tech

FDA ap­proves Astel­las' gas­tric can­cer drug Vy­loy ahead of sched­ule

7 months ago
Pharma

EMA again rec­om­mends against au­tho­riza­tion for PTC Ther­a­peu­tic­s' Translar­na

7 months ago
Pharma

Eu­ro­pean Com­mis­sion to work more close­ly with Eu­ro­pean Med­i­cines Agency

7 months ago
Law

FDA par­tial­ly holds BioN­Tech's Phase 3 an­ti-CT­LA-4, com­pa­ny paus­es en­roll­ment

7 months ago
R&D
Pharma

In­ter­cep­t's liv­er dis­ease drug faces full ap­proval de­lay fol­low­ing neg­a­tive ad­comm

7 months ago
Pharma

FDA fi­nal­izes guid­ance on gener­ic drugs, can­cer tri­als and neona­tal drug de­vel­op­ment

7 months ago

FDA de­lays col­orec­tal can­cer de­ci­sion for Am­gen's Lumakras, a set­back in race with Bris­tol My­ers

7 months ago
Pharma

FDA ex­pands la­bel for Avadel's nar­colep­sy drug in­to chil­dren

7 months ago
Pharma

FDA ap­proves Ab­b­Vie's 24-hour Parkin­son's in­fu­sion ther­a­py af­ter two CRLs

7 months ago
Pharma

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

7 months ago
Pharma

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

7 months ago

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

7 months ago
R&D

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

7 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
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