FDA+ channel feed

CorMedix wins US ap­proval via rarely-used path­way for drug to re­duce blood­stream in­fec­tions

Last year
Pharma

Can post-mar­ket ev­i­dence gen­er­a­tion be stream­lined? FDA-com­mis­sioned re­port pro­pos­es so­lu­tions

Last year
Pharma

FDA rais­es con­cerns over ef­fi­ca­cy of Mer­ck­'s po­ten­tial chron­ic cough drug ahead of ad­comm

Last year
Pharma

Ama­zon lands FDA warn­ing let­ter over dis­tri­b­u­tion of sev­en un­ap­proved eye drops

Last year

New NIH chief stress­es fo­cus on obe­si­ty, clin­i­cal tri­al chal­lenges

Last year
Pharma

FDA touts new au­thor­i­ty as ODAC hosts ad­comm to re­view de­layed con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals

Last year

Japan con­sid­ers ad­just­ing clin­i­cal tri­al re­quire­ments to re­move the need for lo­cal stud­ies — re­port

Last year
Pharma

FDA ex­plains why it de­nied about 60% of non-on­col­o­gy break­through ther­a­py re­quests from 2017 to 2019

Last year
Pharma

EMA com­mit­tee rec­om­mends ap­provals for Lil­ly's weight loss drug, Mi­rati's KRAS in­hibitor and more

Last year
Pharma

House Re­pub­li­cans threat­en to sub­poe­na FDA over Covid re­search doc­u­ments

Last year
Pharma

Val­ne­va re­ceives first chikun­gun­ya vac­cine ap­proval af­ter two month de­lay to FDA re­view

Last year
R&D

FDA ap­proves Takeda's new en­zyme re­place­ment ther­a­py for rare blood clot­ting dis­or­der

Last year

ADF asks SCO­TUS not to take up mifepri­s­tone case as Dan­co, DOJ say ar­gu­ments don't hold up

Last year
Pharma
Law

How Boehringer In­gel­heim and Pfiz­er bat­tled over the ex­clu­siv­i­ty of the first Hu­mi­ra in­ter­change­able

Last year

Take­da scores FDA ap­proval for $400M col­orec­tal can­cer ther­a­py

Last year
Pharma

FDA watch­dog ad­mon­ish­es Evofem for mar­ket­ing brochure for its con­tra­cep­tive Phexxi

Last year
Pharma
Marketing

FDA ap­proves an un­brand­ed ver­sion of megablock­buster Hu­mi­ra, but Ab­b­Vie says it won't 'cur­rent­ly' launch

Last year
Pharma

Sen­ate Fi­nance Com­mit­tee unan­i­mous­ly ad­vances PBM, Medicare Part D re­forms

Last year
Pharma

FDA+ roundup: Fi­nal guid­ance on the fastest on­col­o­gy drug ap­provals; Re­mote in­spec­tions fail to take off

Last year

Up­dat­ed: Eli Lil­ly's tirzepatide breaks in­to obe­si­ty mar­ket with FDA ap­proval

Last year
Pharma

Sen­ate con­firms Mon­i­ca Bertag­nol­li to lead NIH with bi­par­ti­san 62-36 vote

Last year
Pharma

FTC chal­lenges more than 100 drug patents owned by Ab­b­Vie, As­traZeneca, Boehringer and sev­en oth­ers

Last year
Law

'Pull every lev­er': Marks dou­bles down on ur­gency to im­prove gene ther­a­py man­u­fac­tur­ing

Last year
Pharma
Cell/Gene Tx

HHS says Ste­lara may be de­s­e­lect­ed from Medicare ne­go­ti­a­tions, de­pend­ing on biosim­i­lar launch

Last year
Pharma
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