FDA+ channel feed

Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

6 years ago
R&D

Pa­tient reg­istries may prove valu­able in reg­u­la­to­ry de­ci­sions, EMA study finds

6 years ago

FDA, EMA ad­vise on risk-based mon­i­tor­ing in clin­i­cal tri­als

6 years ago

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

6 years ago

With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

6 years ago

FDA warns Strides Phar­ma for un­con­trolled doc­u­ment shred­ding

6 years ago

As ri­vals march on, No­var­tis se­cures pri­or­i­ty FDA re­view for sick­le cell dis­ease ther­a­py

6 years ago
R&D

Eton Phar­ma hand­ed CRL for re­for­mu­lat­ed con­junc­tivi­tis eye drop

6 years ago
R&D

FDA re­vis­es 1999 draft guid­ance on pop­u­la­tion phar­ma­co­ki­net­ics

6 years ago

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
First page Previous page 142143144145146 Next page Last page
A service from the Financial Times