FDA+ channel feed

US spent $3B on DMD treat­ments as con­fir­ma­to­ry stud­ies still un­der­way, JA­MA pa­per says

Last year
Pharma

Biden ad­min­is­tra­tion pro­pos­es fund­ing bump for FDA, nix­ing in­ter­change­abil­i­ty re­quire­ment

Last year
Pharma

FDA puts added em­pha­sis on amy­loid in up­date on Alzheimer's R&D guid­ance

Last year

Vi­a­tris and Mapi eval­u­ate next steps af­ter FDA re­jects long-act­ing MS in­jec­tion

Last year
Pharma

Phar­ma bris­tles at Biden’s call to ex­pand IRA ne­go­ti­a­tions at State of the Union

Last year
Pharma

Up­dat­ed: FDA ap­proves weight loss drug We­govy to re­duce car­dio­vas­cu­lar events

Last year
Pharma

The FDA al­most nev­er pulls ful­ly-ap­proved drugs. Amy­lyx's ALS treat­ment might be the ex­cep­tion

Last year
R&D

In sur­prise move, FDA de­lays de­ci­sion on Lil­ly’s Alzheimer’s drug, will con­vene ad­vi­so­ry com­mit­tee

Last year

BeiGene’s Brukin­sa bags fifth FDA ap­proval, like­ly po­si­tion­ing it for con­tin­ued sales growth

Last year
Pharma

Bris­tol My­ers nabs ap­proval for Op­di­vo com­bo as first-line blad­der can­cer treat­ment

Last year
R&D
Pharma

FDA sees suc­cess in mod­el-in­formed drug de­vel­op­ment pi­lot

Last year
Pharma

Val­isure pres­sures FDA to re­call ac­ne treat­ments af­ter find­ing car­cino­gen

Last year
Pharma

FDA faces flat­lined bud­get as clock ticks for Con­gress to pass gov­ern­ment fund­ing

Last year
Pharma

Eu­ro­pean Com­mis­sion spells out new pro­pos­als for health tech­nol­o­gy as­sess­ments

Last year
Pharma

San­doz wins FDA ap­proval for first two biosim­i­lars for Am­gen's block­buster bone drug

Last year
Pharma

FDA de­nies hear­ing to Van­da on jet lag in­di­ca­tion for sleep dis­or­der drug

Last year
Pharma

Hugel smooths out wrin­kles with FDA, wins ap­proval for Botox com­peti­tor

Last year
Pharma

J&J's Janssen nabs new in­di­ca­tion, full ap­proval for can­cer drug Ry­bre­vant

Last year
R&D

FDA di­rects spon­sors to keep in­formed con­sent in­fo con­cise, tai­lored to par­tic­i­pants

Last year

GAO di­rects ARPA-H to fi­nal­ize plan for han­dling du­pli­cate re­search

Last year
R&D
Pharma

House com­mit­tee de­bates IRA changes that would im­pact or­phan drugs and oth­er ar­eas

Last year
Pharma

Biden ad­min­is­tra­tion in­vests $48M in AI/ML plat­form to iden­ti­fy rare dis­ease drugs

Last year
AI
Pharma

Mod­er­na spells out rare dis­ease am­bi­tions: 'We have a bunch of INDs planned'

Last year
Pharma

Califf lays out drug short­age land­scape, talks post-mar­ket da­ta col­lec­tion for ac­cel­er­at­ed ap­provals

Last year
Pharma
Manufacturing
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