FDA+ channel feed

Up­dat­ed: FDA punts PDU­FA date for an­oth­er in­di­ca­tion for As­traZeneca, Mer­ck­'s can­cer drug Lyn­parza

3 years ago
Pharma

'Pro­ject Re­newal': FDA up­dates old­er Genen­tech can­cer drug la­bel

3 years ago

What should man­u­fac­tur­ers do af­ter re­ceiv­ing a Form 483? FDA ex­plains

3 years ago
Manufacturing

And then there were 8: Fre­se­nius nabs the lat­est Hu­mi­ra biosim­i­lar ap­proval

3 years ago
Pharma

FDA ad­comm votes 8-3 against Cy­to­ki­net­ic­s' po­ten­tial heart fail­ure drug

3 years ago

Short-term gov­ern­ment spend­ing bill in­cludes reau­tho­riza­tions of or­phan drug cred­its and oth­er phar­ma perks

3 years ago
Law

Roche wins ear­li­er-than-ex­pect­ed ap­proval for block­buster Tecen­triq in rare soft tis­sue can­cer

3 years ago
Pharma

Up­dat­ed: FDA ap­proves Mi­rati's KRAS drug in non-small cell lung can­cer

3 years ago
R&D
Pharma

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

3 years ago
Pharma
Manufacturing

FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

3 years ago

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

3 years ago

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

3 years ago
Pharma
Manufacturing

Bro­ken promis­es? FDA needs more pow­er to re­move drugs from mar­ket­place, JA­MA analy­sis finds

3 years ago

Scoop: On­copep­tides CEO ‘lean­ing to­ward’ giv­ing in to FDA with­draw­al re­quest amid ‘piss­ing con­test’ with reg­u­la­tors

3 years ago

FDA com­mis­sion­er on drug ap­provals: The prob­lem is­n't in­no­va­tion or speed

3 years ago

FDA au­tho­rizes bi­va­lent Covid boost­ers for chil­dren 6 months and up

3 years ago
Pharma
Coronavirus

QC vi­o­la­tions raised by FDA at an­oth­er Au­robindo site

3 years ago
Pharma
Manufacturing

FDA halts im­ports of sev­er­al Sun Phar­ma drugs made in In­dia due to out­stand­ing qual­i­ty is­sues

3 years ago
Pharma
Manufacturing

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

3 years ago

Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

3 years ago
Pharma
Manufacturing

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

3 years ago
Pharma

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

3 years ago
Pharma

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

3 years ago
R&D

FDA's drug short­ages leader wants com­pa­nies to start re­port­ing in­creas­es in de­mand

3 years ago
Pharma
Manufacturing
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