Sanofi hints at 'class ef­fec­t' for mR­NA flu shot as it un­veils vac­cine R&D plans dri­ven by $3.2B deal

Last year
R&D
Pharma

In a first, FDA signs off on Cell­Tran­s' type 1 di­a­betes cell ther­a­py days af­ter in­dus­try's eyes fix­at­ed on Ver­tex ...

Last year
R&D
Cell/Gene Tx

FDA ad­comm votes in fa­vor of Ipsen's fi­brodys­pla­sia drug

Last year
R&D
Pharma

Q&A with Tran­sCel­er­ate’s new CEO Jan­ice Chang: Bring­ing the tri­al in­fra­struc­ture to pa­tients

Last year
R&D
FDA+

ICER taps new pres­i­dent as Steve Pear­son an­nounces plans to step down

Last year
People
Pharma

Over­board: Alex­is Borisy will have to lim­it di­rec­tor posts to stay on at Blue­print

Last year
People

Gilead sup­ports cre­ation of on­line re­source hub for Black pa­tients with triple-neg­a­tive breast can­cer

Last year
Pharma
Marketing

A cen­tu­ry af­ter the last ma­jor TB vac­cine break­through, Gates and Well­come com­mit $550M for PhI­II test of GSK shot

Last year
R&D

Im­mutep picks up more funds for LAG-3 on­col­o­gy and au­toim­mune stud­ies

Last year
Financing

Meet ‘Fan­zor,’ a cousin of CRISPR and Feng Zhang’s new gene edit­ing tool

Last year
R&D
Discovery

With just one re­sponse in 47 pa­tients, Foghorn stops work on lead can­di­date in ad­vanced eye can­cer

Last year
R&D

Gene ther­a­py biotech Cap­si­da lays off work­ers af­ter ex­pand­ing Ab­b­Vie pact, adding Lil­ly col­lab

Last year
People
Startups

K36 Ther­a­peu­tics rais­es $70M in Se­ries B to fund mul­ti­ple myelo­ma re­search

Last year
Financing

Eton hand­ed sec­ond CRL for methanol poi­son­ing treat­ment

Last year
R&D
FDA+

FDA plots chal­lenges in im­ple­ment­ing new laws tar­get­ing phar­ma sup­ply chain

Last year
FDA+
Manufacturing

Af­ter CRL in 2022, Pfiz­er and OP­KO get FDA nod for pe­di­atric growth hor­mone de­fi­cien­cy med

Last year
Pharma
FDA+

As­traZeneca ex­pands tree-plant­i­ng ini­tia­tive with an­oth­er $400M to plant 200M trees by 2030

Last year
Pharma

Fresh off ap­proval, Ab­b­Vie and Gen­mab's CD3xCD20 bis­pe­cif­ic Ep­kin­ly scores in an­oth­er type of blood can­cer

Last year
R&D

Cor­rect­ed: Bay­er's Blue­Rock group moves Parkin­son's cell ther­a­py to PhII af­ter clear­ing ear­ly study

Last year
R&D
Cell/Gene Tx

Up­dat­ed: FDA re­jects high­er dose of Re­gen­eron's Eylea af­ter in­spec­tion at con­trac­tor Catal­ent

Last year
FDA+
Manufacturing

A French start­up wants to de­cen­tral­ize cell and gene ther­a­py man­u­fac­tur­ing, mak­ing it 'the size of a book'

Last year
Financing
Cell/Gene Tx

API man­u­fac­tur­er in Chi­na hand­ed warn­ing let­ter af­ter fail­ing to re­spond to the reg­u­la­tor’s re­quests for ...

Last year
FDA+
Manufacturing

Al­most 40 years af­ter an ad­com­m's warn­ing: FDA and spon­sors with­draw ap­proval for an­a­bol­ic steroid

Last year
R&D

FDA, EMA ac­cept Pfiz­er's he­mo­phil­ia B gene ther­a­py, set­ting up show­down with CSL Behring

Last year
Pharma
FDA+
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