Glax­o­SmithK­line scores a win in Zofran case af­ter FDA re­peat­ed­ly said preg­nan­cy risk da­ta did not re­quire la­bel ...

4 years ago
Pharma
FDA+

A ma­jor reshuf­fling at the FDA opened the road for Bio­gen’s Alzheimer’s drug. Can it cross the fin­ish line?

4 years ago
FDA+

Re­ly­ing on an ul­tra-rare vari­ant, David Liu un­veils a new ap­proach to edit­ing sick­le cell

4 years ago
Discovery

Ex­clu­sive: Carl June’s Tmu­ni­ty en­coun­ters a lethal road­block as 2 pa­tient deaths de­rail lead tri­al, raise red flag ...

4 years ago
R&D

Cell­tri­on's rheuma­toid arthri­tis drug meets both end­points in PhI­II; New com­pa­ny Tri­bune emerges to take on fi­brot­ic ...

4 years ago
News Briefing

Lock­ing horns with Ab­b­Vie, J&J boasts post-TNF da­ta for next-gen drug Trem­fya in pso­ri­at­ic arthri­tis

4 years ago
Pharma

Or­chard dis­creet­ly ax­es li­cense for 'bub­ble boy' gene ther­a­py, de­spite re­cent pos­i­tive long-term da­ta up­date

4 years ago
Cell/Gene Tx

Ab­b­Vie's Skyrizi takes home a win in late-stage Crohn's study, adding some heft to its ex­pan­sion plans

4 years ago
Pharma

Gen­mab en­lists an­oth­er an­ti­body con­ju­gate part­ner, team­ing up with Bolt to de­vel­op up to 3 can­cer pro­grams

4 years ago
Deals

Af­ter tak­ing a look at new da­ta, reg­u­la­tors put J&J's BC­MA/CD3 bis­pe­cif­ic on a 'break­through' track

4 years ago
R&D
FDA+

Mor­phoSys swoops in with a $1.7B deal to buy Con­stel­la­tion, adds $2B-plus in Roy­al­ty pact

4 years ago
Deals

Mod­er­na bags an­oth­er US CD­MO to help with fill-fin­ish work for its vac­cine amid boost­er push

4 years ago
Outsourcing
Manufacturing

No­var­tis stakes an­oth­er PhI­II win for Cosen­tyx, goes deep­er in­to pe­di­atric mar­kets

4 years ago
R&D

A sim­ple pa­tient sur­vey rev­o­lu­tion­ized ALS drug de­vel­op­ment in the 1990s. Its cre­ator says it may be time for an ...

4 years ago
R&D
In Focus

Al­most a decade af­ter iden­ti­fy­ing a new class of RNA, a group of sci­en­tists sparks in­ter­est from Take­da Ven­tures

4 years ago
Financing
Startups

Broad In­sti­tute's Er­ic Lan­der con­firmed to Biden cab­i­net; Leg­end re­veals the BC­MA CAR-T da­ta pack­age be­hind pri­or­i­ty ...

4 years ago
News Briefing

Im­muno­vant flash­es se­cret da­ta be­hind po­ten­tial Roivant buy­out, but in­vestors see a dif­fi­cult fu­ture

4 years ago
R&D

Months af­ter ax­ing a Duchenne pro­gram and lay­ing off dozens, San­thera claims a win there with a dif­fer­ent pro­gram

4 years ago
R&D

No­var­tis plots 'next fron­tier' of MS treat­ment — and it could spell a buy­out for a small Swiss play­er

4 years ago
Deals

Mi­rati wins over a Chi­nese part­ner for KRAS hope­ful, look­ing to tail Am­gen's break­through win

4 years ago
Deals

Clin­i­cal stud­ies for AB Sci­ence's all-pur­pose an­ti-in­flam­ma­to­ry drug grind to a halt as com­pa­ny flags po­ten­tial risk ...

4 years ago
R&D

Five more biotechs file their SEC pa­per­work as the IPO Class of 2021 swells to 60

4 years ago
Financing

Alk­er­mes wins FDA nod for com­bo med with an­tipsy­chot­ic olan­za­p­ine — this time with­out the weight gain red flags

4 years ago
FDA+

Covid-19 roundup: Mod­er­na sub­mits vac­cine for full ap­proval; WHO un­veils new Greek-based sys­tem for nam­ing vari­ants

4 years ago
Coronavirus
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