On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

4 years ago
Pharma
FDA+

Oc­u­lar Ther­a­peu­tix ham­mered by a PhII fail­ure in dry eye dis­ease — shares tank

4 years ago
R&D

FDA says ben­e­fits of Covid-19 vac­cine for younger chil­dren out­weigh risks

4 years ago
FDA+
Coronavirus

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

4 years ago
R&D

Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

4 years ago
FDA+

For­mer MIT sci­en­tist David Saba­ti­ni fires back at ac­cuser, White­head In­sti­tute for 'false' ha­rass­ment al­le­ga­tions

4 years ago
People

Fol­low­ing Au­gust melt­down, Zymer­gen hints at sal­vage plans — cut­ting jobs and rene­go­ti­at­ing loans

4 years ago
Pharma

Covid-19 roundup: White House push­es for IP waiv­er sup­port to WTO; Rare nerve dis­or­der list­ed as As­traZeneca side ...

4 years ago
Coronavirus

Sanofi, Re­gen­eron etch out an­oth­er PhI­II vic­to­ry for Dupix­ent, eas­ing se­vere itch and clear­ing le­sions

4 years ago
R&D
Pharma

Brid­get Martell on tak­ing Yale spin­out 'to adult­hood'; Cul­li­nan On­col­o­gy CEO an­nounces res­ig­na­tion as Bris­tol My­ers ...

4 years ago
Peer Review

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

4 years ago
People

House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

4 years ago
Manufacturing

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

4 years ago
FDA+
Manufacturing

Re­call re­port: Glass found in Mer­ck an­tibi­ot­ic threat­ens 22,000 vials

4 years ago
Manufacturing

No­var­tis ex­pands Covid-19 vac­cine man­u­fac­tur­ing deal with Pfiz­er/BioN­Tech; Exacis links with CCRM for NK cell ...

4 years ago
Manufacturing

Fu­ji­film breaks ground on mas­sive NC site, open­ing the path to be­come a man­u­fac­tur­ing pow­er­house

4 years ago
Manufacturing

Short­ly af­ter pump­ing $50M in­to In­di­ana site, Catal­ent will hire up to 600 new em­ploy­ees

4 years ago
Manufacturing

Lian­Bio an­nounces terms for IPO next week; NIH and White House of­fi­cials dis­cuss hy­po­thet­i­cal bio-med re­search agency

4 years ago
News Briefing

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

4 years ago
FDA+

Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

4 years ago
Pharma

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

4 years ago
FDA+

Covid-19 roundup: Pfiz­er/BioN­Tech say boost­er is 95.6% ef­fec­tive; Eu­ro­pean Par­lia­ment calls for more vac­cine ...

4 years ago
Coronavirus

Te­va ap­peals to court to keep 'in­cred­i­bly dam­ag­ing' Hol­ly­wood par­o­dy videos un­der wraps in New York opi­oid case

4 years ago
Pharma
Marketing

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

4 years ago
Financing
Cell/Gene Tx
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