FDA+ channel feed

FDA lead­ers Califf and Paz­dur dish on ac­cel­er­at­ed ap­proval re­forms, sin­gle-coun­try tri­als and an emp­ty White Oak

3 years ago

Up­dat­ed: In sur­prise turn, FDA ad­comm votes in fa­vor of Arde­lyx CKD drug de­spite agency ques­tions

3 years ago
Pharma

UK cost watch­dog drafts guid­ance against 5 Covid treat­ments and J&J de­pres­sion med

3 years ago
Pharma
Coronavirus

Biden looks for $9B+ in new Covid funds as Sen­ate pass­es res­o­lu­tion to end emer­gency de­c­la­ra­tion

3 years ago
Coronavirus

FDA con­tin­ues to ques­tion Arde­lyx CKD drug's ef­fect on clin­i­cal out­comes ahead of ad­comm meet­ing

3 years ago

Up­dat­ed: FDA push­es to make opi­oid over­dose re­ver­sal agents OTC prod­ucts as com­pa­nies balk

3 years ago

FDA be­stows ac­cel­er­at­ed ap­proval on Im­muno­Gen's ovar­i­an can­cer drug, with con­fir­ma­to­ry an­swer com­ing soon

3 years ago

Af­ter CRL, drug de­vel­op­er duo re­sub­mits its ex­per­i­men­tal drug to the FDA, look­ing to com­pete with Fab­razyme

3 years ago
R&D

Seagen's high­est sell­ing drug snags a la­bel ex­pan­sion for pe­di­atric can­cer pa­tients

3 years ago
Pharma

As­traZeneca's can­cer com­bo wins sec­ond nod in one month, this time in lung can­cer

3 years ago
Pharma

Af­ter rare pub­lic brush­back, FDA again turns away Brain­Stor­m's ALS drug with RTF let­ter

3 years ago
R&D

Form 483 cites Lupin man­u­fac­tur­ing site in In­dia for con­t­a­m­i­na­tion and oth­er qual­i­ty con­trol ob­ser­va­tions

3 years ago
R&D
Pharma

FDA ad­comm votes nar­row­ly against Veru's Covid drug, cit­ing un­cer­tain­ties amid mor­tal­i­ty ben­e­fit in small tri­al

3 years ago
R&D

Catch­ing up with Keytru­da, Re­gen­eron scores front­line NSCLC ap­proval for Lib­tayo/chemo com­bo

3 years ago
Pharma

FDA ad­comm of­fers thumbs up on As­traZeneca's 2-in-1 asth­ma in­haler — but on­ly for adults

3 years ago
R&D

FDA warns Bris­tol My­ers Squibb for im­prop­er­ly in­ves­ti­gat­ing con­t­a­m­i­na­tion at site that makes Abrax­ane

3 years ago
Manufacturing

Key to biosim­i­lar com­pe­ti­tion will come from in­ter­change­abil­i­ty, FDA of­fi­cials say

3 years ago

An­oth­er road­block looms for Bio­Mar­in's he­mo­phil­ia A gene ther­a­py — but it might not take too long

3 years ago
Cell/Gene Tx

FDA and PTO look to shore up in­con­sis­ten­cies around phar­ma patents

3 years ago
Pharma

FDA ten­ta­tive­ly hints at EUA, with a tri­al re­quire­ment, for Veru's new Covid drug ahead of ad­comm

3 years ago
Coronavirus

Up­dat­ed: Verve's land­mark base edit­ing tri­al for car­dio drug runs in­to FDA hold

3 years ago
R&D
Cell/Gene Tx

FDA de­lays de­ci­sion for Apel­lis' eye dis­ease drug af­ter biotech sub­mits up­dat­ed da­ta

3 years ago
R&D

Sanofi, As­traZeneca clinch first OK for RSV an­ti­body — just as vac­cines line up at reg­u­la­tors

3 years ago
Pharma

Bio­phar­ma com­pa­nies to FDA: In­ter­na­tion­al­ly har­mo­nize plans to stan­dard­ize safe­ty da­ta and analy­sis

3 years ago
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