FDA+ channel feed

Coin flip: Top an­a­lyst gives Amy­lyx ALS drug a 50% chance at ap­proval as rare sec­ond ad­comm ap­proach­es

3 years ago
R&D

French pen­ny stock will no longer knock on FDA door for ap­proval in a cer­tain type of blood can­cer

3 years ago
R&D

Bio­Marin nets con­di­tion­al ap­proval for val­rox in Eu­rope, mark­ing the first he­mo­phil­ia gene ther­a­py

3 years ago
Cell/Gene Tx

House in­ves­ti­gates Trump’s ‘in­ap­pro­pri­ate’ pres­sure on FDA dur­ing the pan­dem­ic

3 years ago
Coronavirus

In­ter­change­abil­i­ty with­out switch­ing stud­ies: FDA ex­plains why a new Lu­cen­tis biosim­i­lar may be a game-chang­er

3 years ago
Pharma

Why does the FDA se­lect cer­tain drugs for ad­comm meet­ings? Re­searchers want to know

3 years ago
Pharma

So much to say, so lit­tle space. FDA-led stud­ies as­sess risk in­for­ma­tion on so­cial me­dia

3 years ago
Pharma
Marketing

FDA com­mis­sion­er spells out agen­cy's top pri­or­i­ties, with a fo­cus on dis­pelling mis­in­for­ma­tion

3 years ago

FDA con­verts Foghorn's par­tial hold on blood can­cer study to a full pause

3 years ago
R&D

Charg­ing for ex­pand­ed ac­cess drugs: FDA to let com­pa­nies re­coup their costs over time

3 years ago
Pharma

Phar­varis hits a snag with hered­i­tary an­gioede­ma pill as FDA places hold on tri­als

3 years ago

Trick, or treat? FDA plans Hal­loween ad­comm for Ipsen’s sec­ond chance at rare dis­ease drug

3 years ago

Gilead se­cures first lenaca­pavir ap­proval in Eu­rope af­ter lengthy man­u­fac­tur­ing de­lays

3 years ago
R&D

Few­er than 40% of new ac­cel­er­at­ed ap­provals demon­strate 'high' ther­a­peu­tic val­ue, study says

3 years ago
Law

Phar­ma man­u­fac­tur­ers in In­dia, US lat­est to re­ceive qual­i­ty con­trol hits from the FDA

3 years ago
Pharma
Manufacturing

Fol­low­ing an al­most year­long wait, FDA ap­proves Ax­some's rapid-act­ing de­pres­sion drug

3 years ago
Pharma

Bay­er gets FDA nod to ex­tend use of pop­u­lar con­tra­cep­tive IUD Mire­na

3 years ago
Pharma

Cipla man­u­fac­tur­ing site in In­dia lands a Form 483 for un­clean equip­ment, lack of da­ta

3 years ago
Pharma
Manufacturing

Mil­lions more mon­key­pox vac­cine and an­tivi­ral cours­es com­ing to states next week, but will it be enough?

3 years ago
Pharma

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

3 years ago

HHS in­spec­tor gen­er­al: NIH failed to ver­i­fy clin­i­cal tri­al re­sults were re­port­ed on time

3 years ago
Pharma

More than a decade af­ter its ac­cel­er­at­ed ap­proval, vot­ing ques­tions set for pre­ma­ture birth drug's with­draw­al hear­ing

3 years ago
Pharma

FDA grants pri­or­i­ty re­view to Lyn­parza com­bo ther­a­py for metasta­t­ic prostate can­cer

3 years ago
R&D
Pharma

New Hahn-era texts show the ex­tent of the Trump White House­'s in­volve­ment in vac­cine EUA process

3 years ago
Coronavirus
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