Tome plans lay­offs amid strug­gle; FDA turns away Re­gen­eron; Next-gen obe­si­ty start­up launch­es; James Sabry joins ...

8 months ago
Weekly

Gene edit­ing start­up Tome Bio­sciences to lay off al­most all work­ers

8 months ago
People

Re­searchers down­play study that found a link be­tween semaglu­tide and men­tal health

8 months ago
R&D

J&J grants 'short ex­ten­sion' for cer­ti­fi­ca­tion of talc set­tle­ment vote

8 months ago
Pharma
Law

CDER chief says 's­tan­dards have not changed,' ex­plain­ing in­crease in CRLs for bi­o­log­ics

8 months ago
FDA+
Manufacturing

Novo's in­no­va­tion hub ex­pands to Bay Area; SIGA's new Tpoxx or­der

8 months ago
News Briefing

Jazz talk­ing with Japan reg­u­la­tors about an­ti-seizure med Epid­i­olex af­ter tri­al set­back

8 months ago
R&D

Gen­mab makes two C-suite ad­di­tions as COO leaves; James Sabry leads a re­vamped sup­port­ing cast at Bio­Marin

8 months ago
Peer Review

Gene in­ser­tion start­up Tome Bio­sciences stops lab work as CEO shifts fo­cus to deal talks

8 months ago
Startups
Cell/Gene Tx

On­col­o­gy biotech Bicara un­veils IPO pitch same day as Zenas

8 months ago
Financing
Startups

FDA to host ad­comm on PD-L1 as a pre­dic­tive bio­mark­er for check­point in­hibitors

8 months ago
FDA+

Au­toim­mune biotech Zenas files for IPO amid sum­mer lull for pub­lic de­buts

8 months ago
Financing
Startups

FDA ap­proves re­for­mu­lat­ed Covid boost­ers for fall sea­son

8 months ago
Pharma
FDA+

FDA clos­es the door on Intar­ci­a's eight-year bid for di­a­betes drug-de­vice com­bo

8 months ago
FDA+

Liq­uidia sues FDA over ex­clu­siv­i­ty de­ci­sion to de­lay Yutrepi­a's full ap­proval

8 months ago
FDA+
Law

Il­lu­mi­na Ven­tures sets out for $300M third fund

8 months ago
Financing
Startups

Q&A: GSK CSO Tony Wood on stay­ing out of obe­si­ty, 'care­ful' can­cer am­bi­tions, and AI's fu­ture in R&D

8 months ago
People
R&D

Fu­ji­film Diosynth opens new UK fa­cil­i­ty; Bo­ra com­pletes Emer­gent fac­to­ry buy

8 months ago
Manufacturing

How Wal­greens plans to re­vive re­tail phar­ma­cy with­in three years

8 months ago
Health Tech

Dig­i­tal health start­up Sesame starts of­fer­ing com­pound­ed weight loss shots

8 months ago
Startups
Health Tech

Ver­sant and No­var­tis build 'Chi­nook 2.0' for RNA ther­a­pies in kid­ney dis­eases

8 months ago
Financing
Startups

Bio­gen, Ei­sai’s Leqem­bi wins UK ap­proval, but not im­me­di­ate NHS cov­er­age

8 months ago
Pharma

Up­dat­ed: Chi­nese gov­ern­ment in­dicts Japan­ese Astel­las em­ploy­ee for es­pi­onage

8 months ago
People
China

FDA warns hos­pi­tals against us­ing Pfiz­er's re­main­ing potas­si­um in­jec­tions for chil­dren

8 months ago
Pharma
FDA+
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