FDA+ channel feed

FDA en­dors­es new reg­i­men for dead­ly drug-re­sis­tant tu­ber­cu­lo­sis ram­pant in de­vel­op­ing world

6 years ago
R&D
Pharma

The re­al-world ev­i­dence project at the FDA adds Syapse to its list of part­ners in a push past tri­al bound­aries

6 years ago
R&D

As ne­go­ti­a­tions with Eng­land la­bor on, Scot­land re­jects rou­tine use of Ver­tex's cys­tic fi­bro­sis drugs

6 years ago
Pharma

Ques­tions pile up for No­var­tis as sen­a­tors call on FDA to take ac­tion

6 years ago
Cell/Gene Tx

Hu­mana takes aim at Mallinck­rodt's 'ill-got­ten' Ac­thar gains in law­suit

6 years ago
Pharma

FDA so­lic­its in­dus­try in­put for OND pol­i­cy pri­or­i­ties

6 years ago

US sen­a­tors ac­cuse No­var­tis ex­ecs of greed for hid­ing ma­nip­u­lat­ed Zol­gens­ma da­ta — and the next step could af­fect the in­dus­try

6 years ago
Pharma

Fab­ry dis­ease: FDA drafts drug de­vel­op­ment guid­ance

6 years ago

The FDA de­cides to hold an ex­pert pan­el re­view of Vas­cepa af­ter all — and Amarin shares tank on un­ex­pect­ed de­lay

6 years ago
R&D

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
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