FDA+ channel feed

House Re­pub­li­cans threat­en sub­poe­na over de­tails of NIH mpox re­search

Last year

RWD and RWE are not the same: FDA lead­ers dis­pel com­mon mis­con­cep­tions in new pa­per

Last year
Pharma

Nec­tar Life­sciences hit with un­ti­tled let­ter over re­peat GMP is­sues at an­timi­cro­bial site

Last year
Manufacturing

Sam­sung's bi­o­log­ics plant in South Ko­rea re­ceives Form 483 over da­ta in­tegri­ty, oth­er ob­ser­va­tions

Last year
Manufacturing

Risk-ben­e­fit de­ter­mi­na­tions: FDA fi­nal­izes long-await­ed guid­ance for drug­mak­ers

Last year
Pharma

EMA looks in­to fal­si­fied Ozem­pic with Ger­man and Aus­tri­an ori­gins

Last year

NIH di­rec­tor nom­i­nee Bertag­nol­li skirts drug pric­ing ques­tions at con­fir­ma­tion hear­ing

Last year
People
Pharma

FDA al­lows first piv­otal tri­al of an in vi­vo gene edit­ing treat­ment from In­tel­lia

Last year
Cell/Gene Tx

Brain­Storm with­draws ALS drug ap­pli­ca­tion af­ter neg­a­tive ad­comm vote

Last year

Ora­sis gains FDA ap­proval for pres­by­opia eye drops, fol­low­ing in Ab­b­Vie’s foot­steps

Last year
Pharma

FDA ap­proves new in­di­ca­tion for Arde­lyx's tena­panor for serum phos­pho­rus con­trol

Last year
Pharma

FDA ap­proves Mer­ck­'s Keytru­da for be­fore and af­ter lung can­cer surgery

Last year
R&D

US vs. Eu­rope: New re­search pa­per com­pares drug re­view times across bor­ders

Last year
Pharma

Bris­tol My­ers scores an­oth­er Op­di­vo ap­proval, as Mer­ck con­verts AA to full ap­proval for Keytru­da in MCC

Last year
Pharma

PhRMA, top De­moc­rats urge Supreme Court to take up abor­tion pill case

Last year
Law

Aldeyra braces for po­ten­tial dry eye dis­ease re­jec­tion af­ter FDA says more da­ta are nec­es­sary

Last year

Pfiz­er's El­rex­fio, Astel­las' Veozah among new drugs rec­om­mend­ed for au­tho­riza­tion by Eu­ro­pean reg­u­la­to­ry com­mit­tee

Last year
Pharma

BIO, PhRMA, oth­ers seek tweaks to FDA draft guid­ance on di­ver­si­ty in post­mar­ket­ing stud­ies

Last year
Pharma

EU com­mit­tee con­firms neg­a­tive opin­ion for Amy­lyx ALS drug, re­ject­ing com­pa­ny ap­peal

Last year

Pfiz­er lands FDA ap­proval for $6.7B ul­cer­a­tive col­i­tis drug, tak­ing on an­ti­bod­ies as an oral al­ter­na­tive

Last year
R&D
Pharma

Qual­i­ty con­sid­er­a­tions for top­i­cal eye treat­ments: FDA pub­lish­es new draft guid­ance

Last year
Pharma

GSK looks to au­tho­rized gener­ic ver­sion of asth­ma treat­ment as Med­ic­aid re­bate caps lift next year

Last year
Pharma

Alvotech’s Reyk­javik man­u­fac­tur­ing dol­drums con­tin­ue with CRL for Ste­lara biosim­i­lar

Last year
Manufacturing

CMS post­pones na­tion­al cov­er­age de­ter­mi­na­tion for PrEP, says de­ci­sion is 'forth­com­ing'

Last year
Pharma
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