FDA fi­nal­izes guid­ance on us­ing EHR da­ta to sup­port drug sub­mis­sions

10 months ago
FDA+

Rare pe­di­atric PRV reau­tho­riza­tion faces un­cer­tain fate as sum­mer re­cess ap­proach­es

10 months ago
FDA+
Law

In a tough mar­ket, pri­vate biotechs pur­sue IPOs and buy­outs at the same time

10 months ago
Financing
Startups

No­var­tis pays $150M up­front, in­clud­ing $25M in eq­ui­ty, for Dren Bio’s bis­pecifics

10 months ago
Deals

BioN­Tech signs 3D print­ing deal to de­vel­op oral RNA drugs

10 months ago
Deals

Palvel­la’s re­verse merg­er with Pieris; Ab­b­Vie’s VC arm in­vests in an­ti-ag­ing start­up 

10 months ago
News Briefing

BeiGene plots to fur­ther build its man­u­fac­tur­ing mus­cle out­side of Chi­na

10 months ago
China
Manufacturing

Pfiz­er touts Phase 3 gene ther­a­py da­ta in he­mo­phil­ia A, but now it needs to prove it can win the mar­ket

10 months ago
R&D

Sage's es­sen­tial tremor drug fails in an­oth­er blow to pipeline, Bio­gen part­ner­ship

10 months ago
R&D

Chi­nese biotech de­vel­op­ing semaglu­tide biosim­i­lar files for Hong Kong IPO

10 months ago
Financing
China

With new mis­sion in psy­chi­a­try, Au­to­bahn rais­es $100M to help back Phase 2 work

10 months ago
Financing

Ac­tivist in­vestor calls for board shake­up at As­ser­tio, threat­ens proxy con­test

10 months ago
Pharma

Ex­clu­sive: RA Cap­i­tal in­vests $35M in UK can­cer biotech Cell­Cen­tric

10 months ago
Financing
R&D

As­traZeneca signs pre­clin­i­cal EGFR drug deal with an­ti­body biotech

10 months ago
Deals
R&D

PBM ex­ec­u­tives dodge grilling in House com­mit­tee hear­ing

10 months ago
Pharma
Law

FDA asks ad­comm if As­traZeneca needs an­oth­er study on Imfinzi be­fore and af­ter lung can­cer surgery

10 months ago
Pharma
FDA+

Ab­b­Vie files law­suit in Mis­souri fed­er­al court over 340B con­tract phar­ma­cies

10 months ago
Pharma
Law

What's changed about rare dis­ease med­i­cine

10 months ago
R&D

In­di­an man­u­fac­tur­er Bras­si­ca hit with warn­ing let­ter af­ter em­ploy­ees faked da­ta re­sults

10 months ago
FDA+
Manufacturing

Up­dat­ed: Mer­ck, with­out shar­ing de­tails, says RSV an­ti­body suc­cess­ful­ly pro­tect­ed in­fants

10 months ago
R&D
Pharma

Pfiz­er lifts cur­tain on $740M+ ex­ten­sion at API man­u­fac­tur­ing site in Sin­ga­pore

10 months ago
Pharma
Manufacturing

Cel­lec­tar to seek ap­proval for ra­dioac­tive io­dine-based ther­a­py in rare blood can­cer

10 months ago
R&D

Neu­rol­o­gy start­up from Or­biMed col­lab nabs $65M in Se­ries A

10 months ago
Financing
Startups

Telix's $397M con­vert­ible bond of­fer­ing; Scynex­is records a $10M mile­stone

10 months ago
News Briefing
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