Sen­a­tors call on FDA to ad­dress 'del­uge of mis­lead­ing pro­mo­tion­s' on so­cial me­dia

Last year
FDA+
Marketing

Organon's Hu­mi­ra biosim­i­lar gets ex­clu­sive spot on VA for­mu­la­ry

Last year
Pharma
FDA+

GSK and oth­ers delist Or­ange Book patents af­ter FTC tar­gets pro­tec­tions on in­halers and ep­i­neph­rine in­jec­tors

Last year
FDA+

EMA pre­pares for changes to non-in­fe­ri­or­i­ty, equiv­a­lence study guid­ance

Last year
Pharma
FDA+

Bio­phar­ma man­u­fac­tur­ers call for clar­i­ty on FDA's ad­vanced des­ig­na­tion guid­ance 

Last year
FDA+
Manufacturing

FDA ex­pands la­bel for No­var­tis and Roche's block­buster, con­verts EMD Serono's NSCLC drug to full ap­proval

Last year
Pharma
FDA+

FDA sets June de­ci­sion dead­line for po­ten­tial full ap­proval, la­bel ex­pan­sion of Sarep­ta’s Duchenne gene ther­a­py

Last year
Cell/Gene Tx
FDA+

As­traZeneca asks fed­er­al judge to de­cide in its fa­vor in drug price ne­go­ti­a­tions law­suit

Last year
Pharma
Law

De­nali re­ports a PhII ALS fail as RIPK1 deal with Sanofi hits an­oth­er bump

Last year
R&D

Sofinno­va’s Ma­ha Katabi on re­cent M&A and IPO suc­cess and how deal flow has ‘nev­er been any bet­ter’

Last year
People
Financing

XO­MA to buy Kin­nate; A pain biotech’s small IPO

Last year
News Briefing

Af­ter pa­tient out­cry, Taysha starts to of­fload drug pro­grams

Last year
R&D
Cell/Gene Tx

Athos, an au­toim­mune and can­cer biotech, is rais­ing $35M for clin­i­cal tri­als

Last year
Financing
Startups

In­ven­ti­va stock sinks 20% af­ter se­ri­ous ad­verse event in NASH tri­al leads to en­roll­ment pause

Last year
R&D

Gilead stops re­cruit­ment in CD47 sol­id tu­mor tri­als, a week af­ter it axed blood can­cer de­vel­op­ment

Last year
R&D

Gri­fols fam­i­ly to step away fur­ther from op­er­a­tions; en­Gene CEO re­signs, cit­ing health rea­sons

Last year
People
Peer Review

Astel­las pur­sues ‘con­vert­ible’ in vi­vo CAR-T cell ther­a­pies with Kelo­nia Ther­a­peu­tics

Last year
Deals
Cell/Gene Tx

FDA goes af­ter web­sites mar­ket­ing 'u­nap­proved' semaglu­tide, tirzepatide

Last year
Pharma
FDA+

Es­hoo calls out FDA for miss­ing dead­line on di­ver­si­ty ac­tion plan guid­ance

Last year
Pharma
FDA+

GSK re­fresh­es ‘Shin­gles doesn’t care’ cam­paign with fo­cus on hard­er-to-reach groups

Last year
Pharma
Marketing

Marks re­hash­es Covid-19 ap­proval time­line, de­fends vac­cines for chil­dren at hear­ing

Last year
Pharma
FDA+

FDA com­mis­sion­er hints at car­dio-re­lat­ed la­bel ex­pan­sion for We­govy, full ap­proval for Lil­ly's new Alzheimer's drug

Last year
FDA+

No­vo-Catal­ent deal like­ly to be one-off — with some caveats, in­sid­ers say

Last year
Deals
Manufacturing

VBI sells vac­cine and fa­cil­i­ty for $33M; Bay­er gets ra­dioiso­topes from Pan­Tera; Ther­mo Fish­er’s PPD ex­pands ...

Last year
Manufacturing
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