Months af­ter pulling on­ly drug from US, On­copep­tides takes back with­draw­al re­quest — but stays mum on why

4 years ago
FDA+
Marketing

Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

4 years ago
R&D

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and ...

4 years ago
Weekly

Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

4 years ago
Pharma
Marketing

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

4 years ago
Pharma
FDA+

Yingli Phar­ma brings small mol­e­cule re­search to the US in new pact with MD An­der­son; UCB's pso­ri­at­ic arthri­tis drug ...

4 years ago
News Briefing

An­oth­er day, an­oth­er xeno­trans­plant, as Unit­ed Ther­a­peu­tics looks to beat com­peti­tors to sci-fi-es­que break­through

4 years ago
Pharma

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ...

4 years ago
FDA+

Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

4 years ago
Coronavirus

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

4 years ago
Pharma

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

4 years ago
Outsourcing
FDA+

So what ex­act­ly does Ver­i­ly do? A new deal with L'Oréal does­n't clear up much

4 years ago
Deals

As Hal Bar­ron steals the show, there’s no off po­si­tion on the John Maraganore switch; Dan­ny Bar-Zo­har makes an­oth­er ...

4 years ago
Peer Review

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

4 years ago
FDA+

Pub­li­cis Health snaps up R&D mar­ket­ing group track­ing re­al-world clin­i­cal tri­als – and pa­tient sen­ti­ment

4 years ago
Pharma
Marketing

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

4 years ago
Manufacturing

Califf on ac­cel­er­at­ed ap­provals: Com­pa­nies need to do more work be­fore FDA says OK

4 years ago
FDA+

Psy­che­delics biotech set to go pub­lic via SPAC — push­ing IV form of psilo­cy­bin in­to PhI

4 years ago
Financing

A high-res mi­cro­scope the size of a toast­er? A mi­croscopy start­up earns big-name VC back­ers

4 years ago
Financing

Re­call re­port: Miss­ing la­bel, mi­cro­bial con­t­a­m­i­na­tion leads to re­call of two batch­es of two drugs

4 years ago
Manufacturing

Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

4 years ago
Manufacturing

Mer­ck com­mer­cial chief Frank Clyburn de­parts for CEO role at DuPont co-owned ad­di­tives com­pa­ny

4 years ago
Pharma
Marketing

Covid-19 man­u­fac­tur­ing roundup: New pro­duc­tion site opens in Africa; Sen­a­tor calls for test prices to be slashed

4 years ago
Manufacturing

Johns Hop­kins and lo­cal biotech team up for new man­u­fac­tur­ing site; New oral drug plat­form to help ac­cel­er­ate R&D ...

4 years ago
Manufacturing
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