Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

3 years ago
FDA+

Up­dat­ed: Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

3 years ago
R&D

Civi­ca, Mayo Clin­ic and oth­ers sound off on FDA draft guid­ance to mit­i­gate drug short­ages

3 years ago
Pharma
FDA+

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

3 years ago
Pharma

To avoid short­age of Mer­ck­'s di­a­betes drug, FDA al­lows high­er im­pu­ri­ty lev­els tem­porar­i­ly

3 years ago
FDA+
Manufacturing

Work­ers at Pfiz­er Aus­tralian man­u­fac­tur­ing site the lat­est to walk out in la­bor dis­pute protests

3 years ago
People
Pharma

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

3 years ago
Pharma
Marketing

Mar­ket­ingRx roundup: Ab­b­Vie re­fresh­es Skyrizi and Rin­voq cam­paigns; Ab­bott inks Weight­Watch­ers deal

3 years ago
Pharma
Marketing

BioCryst re­sumes en­roll­ment for im­mune dis­eases drug; Ea­gle buys stake in res­pi­ra­to­ry dis­ease biotech

3 years ago
News Briefing

Verona’s COPD drug shines in PhI­II study, po­ten­tial­ly clear­ing path to FDA — shares jump

3 years ago
R&D

BeiGene touts pos­i­tive PhI­II da­ta on tislelizum­ab in af­ter­math of set­backs at FDA

3 years ago
R&D

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

3 years ago
FDA+

On an ex­pan­sion spree, Ger­man man­u­fac­tur­er Sar­to­rius makes $500M+ pur­chase of cell cul­ture me­dia play­er

3 years ago
Deals
Outsourcing

Covid-19 roundup: De­sert­ed by Roche and plagued by set­backs, Atea march­es on; Eu­rope lines up or­der for Mod­er­na's ...

3 years ago
Coronavirus

Rea­ta’s ‘reg­u­la­to­ry con­cerns’ turn in­to three-month de­lay on FDA de­ci­sion for Friedre­ich’s atax­ia drug

3 years ago
R&D
FDA+

Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

3 years ago
Deals

Ko­di­ak man­ages to score a win for its Eylea ri­val — but the ma­jor test is still ahead

3 years ago
R&D

Karuna looks to build on pos­i­tive schiz­o­phre­nia da­ta with one of the biggest pub­lic rais­es this year

3 years ago
Financing

CorMedix hit with sec­ond CRL for an­ti­fun­gal treat­ment, cit­ing man­u­fac­tur­ing and API is­sues

3 years ago
FDA+
Manufacturing

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

3 years ago
R&D
In Focus

US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

3 years ago
Pharma
Coronavirus

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

3 years ago
People

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

3 years ago
Pharma

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

3 years ago
Deals
Pharma
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