Af­ter years of fail­ure, Vi­a­Cyte shows off first proof-of-con­cept for di­a­betes stem cell trans­plants

4 years ago
R&D

EU reg­u­la­to­ry com­mit­tee rec­om­mends 8 new drugs for ap­proval, in­clud­ing Bris­tol My­er­s' BC­MA CAR-T

4 years ago
FDA+

US paus­es use of Eli Lil­ly's Covid-19 treat­ment na­tion­wide due to vari­ants

4 years ago
FDA+
Coronavirus

ACIP unan­i­mous­ly rec­om­mends Deng­vax­ia use, with same caveats as FDA la­bel; Chi­nese 3D print­ing com­pa­ny with ...

4 years ago
News Briefing

FDA push­es back de­ci­sions on Ab­b­Vie's Rin­voq sNDAs to fur­ther re­view a failed Pfiz­er tri­al

4 years ago
R&D
FDA+

With Glax­o­SmithK­line in the rearview mir­ror, Ab­bas Hus­sain is ready to lead a biotech of his own; Doug Tre­co scores ...

4 years ago
Peer Review

Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing

4 years ago
Financing

Re­call re­port: Pfiz­er puts a stop on Chan­tix dis­tri­b­u­tion af­ter traces of pos­si­ble car­cino­gens found

4 years ago
Manufacturing

Mi­rati steps on the gas with KRAS in­hibitor, look­ing to claim sec­ond ap­proval be­hind Am­gen's Lumakras

4 years ago
FDA+

Covid-19 roundup: Pieris to in­ves­ti­gate treat­ment of long Covid with Bavar­i­an grant mon­ey; A roller­coast­er year ends ...

4 years ago
R&D
Coronavirus

House draft 2022 spend­ing bill: $86M less for FDA than what Biden re­quest­ed

4 years ago
FDA+

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

4 years ago
FDA+

With the ground bro­ken on a Van­cou­ver head­quar­ters, an­ti­body mak­er Ab­Cellera will add man­u­fac­tur­ing space next door

4 years ago
Manufacturing

Emer­gen­t's bad year con­tin­ues with House over­sight com­mit­tee de­mand­ing doc­u­ments tied to vac­cine screwup

4 years ago
Manufacturing

J&J, Leg­end un­veil plans for Bel­gian cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty as the part­ners await ap­proval for lead drug

4 years ago
Manufacturing

A French CD­MO looks to add even more cell and gene ther­a­py ca­pac­i­ty at a Paris-area site

4 years ago
Outsourcing
Manufacturing

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

4 years ago
People
Manufacturing

Covid-19 man­u­fac­tur­ing roundup: Smug­gled remde­sivir seized en route to Mex­i­co; As Sput­nik awaits WHO ap­proval, a ...

4 years ago
Outsourcing
Manufacturing

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

4 years ago
R&D

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

4 years ago
R&D
FDA+

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

4 years ago
Deals

Ab­b­Vie snaps up a bis­pe­cif­ic for mul­ti­ple myelo­ma in TeneoOne buy­out; Ver­tex launch­es $1.5B share buy­back pro­gram

4 years ago
News Briefing

Roche sev­ers ties with 4D Mol­e­c­u­lar Ther­a­peu­tics over blind­ness gene ther­a­py, mark­ing an­oth­er set­back for the field

4 years ago
Deals

Sen­a­tors call for hear­ing to ex­am­ine how Medicare will han­dle Bio­gen's new Alzheimer's drug

4 years ago
R&D
FDA+
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