FDA+ channel feed

The FDA's Janet Wood­cock talks about some big changes she's push­ing for in drug de­vel­op­ment, and agency re­views

6 years ago
People

UK courts an­tibi­ot­ic de­vel­op­ers with 'sub­scrip­tion-style' in­cen­tive to com­bat su­per­bug scourge

6 years ago
R&D

Fed­er­al judge scut­tles Trump's rule man­dat­ing drug prices in TV ads

6 years ago
Pharma

Epi­der­mol­y­sis bul­losa: FDA seeks to help de­vel­op­ment of new treat­ments

6 years ago

Five US states agree to sus­pend lit­i­ga­tion against bank­rupt opi­oid mak­er In­sys — re­port

6 years ago

Em­bold­ened by AS­CO da­ta, FDA etch­es speedy ap­proval path for Io­vance's cer­vi­cal can­cer ther­a­py

6 years ago

Watch out Ab­b­Vie: Gilead is fast on your heels at the FDA with ri­val JAK in­hibitor fil­go­tinib

6 years ago
R&D

Bull­ish Amarin dou­bling sales force in fast run-up to the big FDA de­ci­sion on Vas­cepa

6 years ago
R&D

Am­gen/UCB hit an­oth­er Eveni­ty hur­dle, as Eu­ro­pean reg­u­la­tors fail to back the os­teo­poro­sis drug

6 years ago

Trans­paren­cy: FDA to re­lease more in­fo on pre­mar­ket re­views

6 years ago

While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

6 years ago

FDA re­jects Ac­er's rare dis­ease drug, asks for new tri­al — shares crater

6 years ago
R&D

GSK/Tesaro PARP in­hibitor Ze­ju­la wins an­oth­er speedy re­view

6 years ago

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

6 years ago
R&D

FDA spurns hay fever drug from In­di­a's Glen­mark

6 years ago
Pharma

New study ques­tions the need for 12 years of mar­ket ex­clu­siv­i­ty for bi­o­log­ics

6 years ago

Study: Just half of post­mar­ket­ing com­mit­ment tri­als are pub­lished

6 years ago
R&D

Drug­mak­ers sue HHS for try­ing to add prices to DTC ads

6 years ago
Pharma

FDA warns of one death linked to fe­cal trans­plants

6 years ago
R&D

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

6 years ago
Pharma

CDER drafts drug de­vel­op­ment guid­ance on NASH with com­pen­sat­ed cir­rho­sis

6 years ago

The FDA is forc­ing a small an­tibi­ot­ic play­er back to the clin­ic for a new tri­al — 10 years af­ter first re­jec­tion

6 years ago
R&D

Amarin gets a boost from the FDA as reg­u­la­tors promise speedy Vas­cepa de­ci­sion — but what about that pan­el re­view?

6 years ago
R&D

FDA should re­assess post­mar­ket tri­als for can­cer drugs ap­proved via ac­cel­er­at­ed path­way, re­searchers say

6 years ago
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