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Hel­lo, neffy: FDA ap­proves first nasal spray for se­vere al­ler­gic re­ac­tions

9 months ago
Pharma
FDA+

Genen­tech, Gilead push FDA to mod­ern­ize re­search in­spec­tions

9 months ago
R&D
FDA+

Al­fasig­ma's PBC treat­ment Ocali­va to face an FDA ad­comm in Sep­tem­ber

9 months ago
Pharma
FDA+

23andMe trades drug dis­cov­ery for GLP-1 weight loss pre­scrip­tions

9 months ago
Pharma
Health Tech

Au­toim­mune CAR-Ts are un­der the mi­cro­scope af­ter Ca­balet­ta’s safe­ty is­sue in lu­pus

9 months ago
R&D

Avid­i­ty CEO says it's ‘full steam ahead’ in DMD as stock ral­lies on Phase 1/2 win

9 months ago
R&D

A CAR-T deal in Chi­na; Zevra’s $60M of­fer­ing

9 months ago
News Briefing

No­vavax plots to re­duce Eu­ro­pean foot­print to be­come a ‘lean­er’ com­pa­ny

9 months ago
Pharma
Manufacturing

FDA lifts hold on 4DMT's Fab­ry gene ther­a­py

9 months ago
R&D
Cell/Gene Tx

Mer­ck pays $700M for clin­i­cal-stage CD3xCD19 bis­pe­cif­ic an­ti­body

9 months ago
Deals
China

Ex­clu­sive: MIT spin­out launch­es with fo­cus on im­prov­ing DNA pay­loads for gene in­ser­tion

9 months ago
Financing
Startups

Bill Haney's Drag­on­fly nabs for­mer Cerev­el CFO; Cel­lec­tis' new CMO

9 months ago
People
Peer Review

In­fec­tious dis­ease biotech un­der­goes makeover af­ter lung dis­ease tri­al un­der­whelms

9 months ago
People
R&D

Gilead shells out $320M to J&J to buy out rare liv­er dis­ease drug roy­al­ties

9 months ago
Deals
Pharma

Pur­due’s emer­gency opi­oid over­dose treat­ment is ap­proved by the FDA

9 months ago
Pharma
FDA+

Aldeyra to re­sub­mit dry eye dis­ease drug this year fol­low­ing pos­i­tive Phase 3 da­ta

9 months ago
R&D

Lil­ly says to ‘take some cau­tion’ on oth­er com­pa­nies’ ear­ly-stage obe­si­ty da­ta, calls out com­pounders

9 months ago
Pharma

Lil­ly con­tributes to iso­tope sup­pli­er fundraise; Lay­offs at Aji­nomo­to   

9 months ago
Manufacturing

WuXi Bio gains some trac­tion in Eu­rope in the face of Biose­cure threat in the US

9 months ago
China
Manufacturing

FDA ap­proves Citius Phar­ma's non-Hodgkin lym­phoma drug Lym­phir

9 months ago
Pharma
FDA+

Lil­ly’s an­ti-tau pill for Alzheimer’s fails in Phase 2 study

9 months ago
R&D

Apel­lis and So­bi land an­oth­er late-stage win for rare kid­ney dis­ease drug

9 months ago
R&D

Am­neal Phar­ma's ex­tend­ed-re­lease Park­ison's treat­ment clinch­es FDA ap­proval

9 months ago
Pharma
FDA+

In­tel­lia’s gene edit­ing ther­a­py suc­ceeds in Phase 2 ge­net­ic swelling con­di­tion study

9 months ago
R&D
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