Regulatory channel feed

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

21 hours ago
Pharma
R&D

Clear­side Bio­med­ical pre­dicts its uveitis drug will be re­ject­ed, af­ter FDA re­quests more da­ta

Yesterday
R&D
Regulatory

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

Yesterday
Regulatory

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Yesterday
People
Pharma

Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal ...

2 days ago
Regulatory
Startups

SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

2 days ago
Regulatory

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

3 days ago
Regulatory

FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

3 days ago
R&D
Regulatory

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

4 days ago
R&D
Regulatory

EMA and FDA his­tor­i­cal­ly agree on just about every new drug ap­proval, but is that slow­ly chang­ing?

5 days ago
Regulatory

Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Last week
Pharma
Regulatory

New re­search ques­tions FDA’s re­liance on and in­abil­i­ty to en­force post­mar­ket­ing re­quire­ments

Last week
Regulatory

One of the 'mir­a­cle cures' to hit the streets is re­al­ly just in­dus­tri­al bleach — and it can kill you

Last week
Regulatory

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

Last week
Pharma
R&D

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

Last week
R&D
Regulatory

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

Last week
Pharma
Regulatory

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

Last week
Cell/Gene Tx
Regulatory

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

Last week
Pharma
Regulatory

FDA so­lic­its in­dus­try in­put for OND pol­i­cy pri­or­i­ties

Last week
Regulatory

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

Last week
Pharma
Regulatory

Fab­ry dis­ease: FDA drafts drug de­vel­op­ment guid­ance

2 weeks ago
Regulatory

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

3 weeks ago
R&D
Regulatory

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

3 weeks ago
Regulatory

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

3 weeks ago
Pharma
Regulatory
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