FDA+ channel feed

Set­ting up a show­down with Boehringer, Pfiz­er scores in­ter­change­abil­i­ty tag for its Hu­mi­ra biosim­i­lar

Last year
Pharma

Up­dat­ed: Two years on from con­fir­ma­to­ry tri­al halt, FDA sub­mits more ques­tions to On­copep­tides over Pepax­to with­draw­al

Last year
R&D

Cal­i­for­nia gov­er­nor ve­toes bill to cap in­sulin prices at $35 per month

Last year
Pharma

FDA re­jects Al­ny­lam’s On­pat­tro la­bel ex­pan­sion af­ter ad­comm vot­ed in fa­vor

Last year
R&D
Pharma

CBO analy­sis calls for more re­search in­to sav­ings po­ten­tial for obe­si­ty treat­ments

Last year
Pharma

Ar­cutis wins la­bel ex­pan­sion for younger use of pso­ri­a­sis cream Zo­ryve

Last year
Pharma

FDA's on­col­o­gy ad­comm votes against Am­gen's con­fir­ma­to­ry da­ta for Lumakras in cer­tain types of NSCLC

Last year

Rea­gan-Udall Foun­da­tion lays out meth­ods for FDA to com­bat mis­in­for­ma­tion

Last year
Pharma

FDA hands down par­tial clin­i­cal hold to In­nate Phar­ma for can­cer drug tri­als af­ter pa­tient death

Last year

FDA's on­col­o­gy ad­vi­so­ry com­mit­tee backs po­ten­tial high-risk neu­rob­las­toma treat­ment

Last year

Slew of phar­ma in­dus­try play­ers form coali­tion to push back against an­titrust re­form

Last year
Pharma

Clin­i­cal ef­fi­ca­cy stud­ies should not be the de­fault for biosim­i­lars de­vel­op­ment, FDA says

Last year

FDA clears No­vavax’s fall boost­er for Covid-19, weeks af­ter mR­NA vac­cine boost­ers 

Last year
Pharma
Coronavirus

FDA of­fers pos­i­tive sig­nals for po­ten­tial pe­di­atric neu­rob­las­toma drug ahead of ODAC meet­ing

Last year

FDA re­jects Gal­der­ma’s liq­uid neu­ro­tox­in due to CMC is­sues 

Last year
Manufacturing

No­vo Nordisk se­cures FDA ap­proval of RNAi ther­a­py from $3.3B Dicer­na takeover

Last year
Pharma

Bio­gen nabs FDA ap­proval for its biosim­i­lar of arthri­tis and Covid-19 drug Actem­ra

Last year
Pharma

Fed­er­al judge de­nies Cham­ber of Com­merce's ef­fort to block IRA's Medicare drug price ne­go­ti­a­tion pro­vi­sions

Last year
Pharma

No­var­tis to seek ac­cel­er­at­ed ap­proval for oral com­ple­ment in­hibitor in rare kid­ney dis­ease

Last year
R&D

FDA re­jects Eli Lil­ly’s eczema drug due to third-par­ty man­u­fac­tur­ing is­sues 

Last year
Manufacturing

FDA rolls out long-await­ed pro­pos­al to over­haul di­ag­nos­tics reg­u­la­tion

Last year

FDA un­veils new rare dis­ease pi­lot pro­gram to in­crease agency-spon­sor com­mu­ni­ca­tions

Last year

Up­dat­ed: Quince eyes PhI­II tri­al start for rare pe­di­atric dis­ease drug-de­vice as FDA lifts clin­i­cal hold

Last year

FDA ap­proves ma­jor de­pres­sive drug af­ter re­ject­ing it mul­ti­ple times in past two decades

Last year
First page Previous page 43444546474849 Next page Last page
A service from the Financial Times