FDA+ channel feed

More re­search is need­ed to jus­ti­fy use of 'med­i­c­i­nal' cannabis: UK agen­cies

6 years ago

CMS will now cov­er pricey CAR-T ther­a­pies for Medicare pa­tients

6 years ago
Pharma

Faced with an­oth­er ethics scan­dal, No­var­tis CEO Vas Narasimhan as­sures an­a­lysts they tried to do 'the right thing'

6 years ago
Pharma

In draft guid­ance, NICE fails to back Clo­vis's PARP in­hibitor Rubra­ca

6 years ago
Pharma

Close to a decade af­ter Eli Lil­ly killed it, Jef­frey Blue­stone's 'break­through' drug is back and be­ing steered to the FDA

6 years ago
R&D

CMS pre­scribes pay­ment fix to re­sus­ci­tate US an­tibi­ot­ic in­dus­try

6 years ago

FDA-EMA work­shop dis­cuss­es qual­i­ty chal­lenges for PRIME, break­through ther­a­pies

6 years ago

FTC in­ves­ti­gates J&J con­tracts re­gard­ing the drug­mak­er's block­buster Rem­i­cade

6 years ago
Pharma

No­var­tis’ Zol­gens­ma joins grow­ing list of med­i­cines to lose ac­cel­er­at­ed as­sess­ment sta­tus in EU

6 years ago

Fol­low­ing EMA, FDA re­stricts use of high-dose Xel­janz, warn­ing of added risks for the block­buster JAK

6 years ago

Nek­tar takes a hit as the FDA swerves away from opi­oid re­views — leav­ing NK­TR-181 in lim­bo

6 years ago
R&D

FDA’s Wood­cock weighs in on role of NIH in drug de­vel­op­ment

6 years ago
People

In­tra-Cel­lu­lar shares mauled as a firestorm of spec­u­la­tion over ad­comm can­cel­la­tion spreads across BioTwit­ter

6 years ago

Sharp­less out­lines FDA’s key pri­or­i­ties for ad­vanc­ing pub­lic health

6 years ago

FDA dis­cuss­es RWD, RWE with in­dus­try, acad­e­mia

6 years ago

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
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