Regulatory channel feed

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

2 days ago
Regulatory

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

3 days ago
Regulatory

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

3 days ago
Regulatory

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

4 days ago
Regulatory

FDA warns Strides Phar­ma for un­con­trolled doc­u­ment shred­ding

4 days ago
Regulatory

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

5 days ago
R&D
Regulatory

Eton Phar­ma hand­ed CRL for re­for­mu­lat­ed con­junc­tivi­tis eye drop

6 days ago
R&D
Regulatory

FDA re­vis­es 1999 draft guid­ance on pop­u­la­tion phar­ma­co­ki­net­ics

Last week
Regulatory

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

Last week
People
Regulatory

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

Last week
R&D
Regulatory

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

Last week
Pharma
Regulatory

Epi­der­mol­y­sis bul­losa: FDA seeks to help de­vel­op­ment of new treat­ments

3 weeks ago
Regulatory

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

3 weeks ago
Regulatory

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

3 weeks ago
Regulatory

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

3 weeks ago
R&D
Regulatory

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

3 weeks ago
R&D
Regulatory

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

4 weeks ago
Regulatory

Trans­paren­cy: FDA to re­lease more in­fo on pre­mar­ket re­views

4 weeks ago
Regulatory

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

4 weeks ago
Regulatory

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

4 weeks ago
R&D
Regulatory

GSK/Tesaro PARP in­hibitor Ze­ju­la wins an­oth­er speedy re­view

4 weeks ago
Regulatory

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

4 weeks ago
R&D
Regulatory

FDA spurns hay fever drug from In­di­a's Glen­mark

4 weeks ago
Pharma
Regulatory

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

Last month
Regulatory
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