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Am­i­cus ex­ecs get back up smil­ing af­ter be­ing scuffed again by lat­est set­back

3 years ago
FDA+

Changes afoot at GSK; The first vic­tim of IRA?; As work halts, fam­i­lies be­hind gene ther­a­py seek con­trol; and more

3 years ago
Weekly

Cit­ing too many da­ta con­founders, FDA ad­comm unan­i­mous­ly votes against Y-mAb­s' drug for rare brain can­cer

3 years ago
Pharma
FDA+

Paul Hud­son pre­dicts de­layed im­pact on Sanofi from Biden's IRA, as Dupix­ent beats last quar­ter's sales

3 years ago
Pharma

Up­dat­ed: A short­age of amox­i­cillin is now be­ing re­port­ed by sev­er­al man­u­fac­tur­ers

3 years ago
Pharma
Manufacturing

EMA lim­its use of JAK in­hibitors for at-risk groups in wake of safe­ty con­cerns

3 years ago
Pharma
FDA+

Ab­b­Vie preps for an on­slaught of Hu­mi­ra biosim­i­lars in 2023, with Skyrizi and Rin­voq to fill the gap for now

3 years ago
Pharma

Gilead finds 'crit­i­cal holes' in the gov­ern­men­t's HIV patent case against it

3 years ago
Pharma
Law

FDA loosens mar­ket­ing rules for au­tho­rized Covid drugs, but will it move the nee­dle?

3 years ago
Pharma
Marketing

Cu­ria breaks ground on $100M ex­pan­sion project in New Mex­i­co

3 years ago
Pharma
Manufacturing

NIH to study Pfiz­er's Paxlovid in long Covid as de­mand — and in­fec­tions — con­tin­ue to fall

3 years ago
Coronavirus

In fi­nal piv­ot from can­cer to rare dis­ease, Agios of­floads its share of Tib­so­vo roy­al­ties for $131M

3 years ago
Deals

Af­ter months of back and forth, Mereo and its biggest stock­hold­er reach truce, re­place board mem­bers

3 years ago
People
Pharma

Pen­ny stock forges ahead with an NDA for Duchenne treat­ment, seek­ing pri­or­i­ty re­view

3 years ago
R&D
FDA+

Tak­ing on Big Phar­ma ri­vals, biotech start­up un­veils first-in-hu­man da­ta on ROS1 drug

3 years ago
R&D

Black­stone in­vests $50M in PTC, lines up $1B loan to sup­port deal­mak­ing

3 years ago
Financing

As 'low­er than pro­ject­ed' da­ta send it back to the draw­ing board, Sanofi takes $1.6B hit on IL-2

3 years ago
R&D
Pharma

Two Au­rinia ex­ecs are out — and CRISPR’s op­er­a­tions chief is­n't far be­hind; Bio­gen MS leader jumps to Eli Lil­ly ...

3 years ago
Peer Review

Seagen touts progress for Pad­cev and Tukysa as it con­tin­ues CEO search

3 years ago
Pharma

Gilead­'s $1.7B hep D drug just ran in­to a road­block at the FDA

3 years ago
Pharma
FDA+

Bris­tol My­ers ex­pands can­cer sur­vivor cam­paign with ac­tor and spokesper­son Ster­ling K. Brown

3 years ago
Pharma
Marketing

FDA rais­es ef­fi­ca­cy con­cerns with Y-mAb­s' po­ten­tial ther­a­py for pe­di­atric neu­rob­las­toma ahead of ODAC meet­ing

3 years ago
R&D
FDA+

Mer­ck CEO Rob Davis has busi­ness de­vel­op­ment on the brain as he builds 'pipeline of the fu­ture'

3 years ago
Pharma

In next step of opi­oid saga, McK­in­sey reach­es pro­posed agree­ment with school dis­tricts and lo­cal gov­ern­ments

3 years ago
Pharma
Law
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