FDA+ channel feed

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

4 years ago

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

4 years ago
R&D

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

4 years ago

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

4 years ago
Coronavirus

Small biotech Viking slapped with clin­i­cal hold af­ter FDA says its PhIb tri­al is ac­tu­al­ly PhII

4 years ago

Months af­ter pulling on­ly drug from US, On­copep­tides takes back with­draw­al re­quest — but stays mum on why

4 years ago
Marketing

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

4 years ago
Pharma

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

4 years ago

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

4 years ago
Outsourcing

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

4 years ago

Califf on ac­cel­er­at­ed ap­provals: Com­pa­nies need to do more work be­fore FDA says OK

4 years ago

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

4 years ago
Pharma

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

4 years ago

Gilead says a net­work of sup­pli­ers and dis­trib­u­tors sold tens of thou­sands of fake ver­sions of its HIV meds

4 years ago
Pharma

A Tony Coles Parkin­son's biotech, Yu­man­i­ty, con­tin­ues its back­slide as lead pro­gram earns a par­tial hold

4 years ago

Al­most three years af­ter whiff­ing in a con­fir­ma­to­ry study, Mer­ck touts new da­ta for Keytru­da in HCC

4 years ago

No stranger to head­winds, blue­bird runs in­to two PDU­FA de­lays un­re­lat­ed to new safe­ty is­sues

4 years ago
R&D

With few re­main­ing un­ap­proved drugs, re­searchers tell FDA its Un­ap­proved Drugs Ini­tia­tive is no longer ef­fec­tive

4 years ago

CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

4 years ago
Pharma

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

4 years ago
Pharma

Eu­rope preps for the launch of its new clin­i­cal tri­als data­base, with a push to in­crease tri­al par­tic­i­pa­tion

4 years ago

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

4 years ago

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

4 years ago
Outsourcing

Wood­cock de­fends FDA's re­sponse to Omi­cron be­fore Sen­ate health com­mit­tee

4 years ago
Coronavirus
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