Pharma channel feed

Bris­tol My­ers wins ap­proval for KRAS drug Kraza­ti in col­orec­tal can­cer

11 months ago
FDA+

FDA widens Sarep­ta’s Duchenne gene ther­a­py la­bel to old­er boys in sig­nif­i­cant ex­pan­sion of use

11 months ago
Cell/Gene Tx
FDA+

Zealand Phar­ma hits ear­ly ef­fi­ca­cy goal for amylin weight loss can­di­date

11 months ago
R&D

FDA to phar­ma com­pa­nies: Us­ing CRO Synapse's stud­ies 'u­nac­cept­able'

11 months ago
Outsourcing
FDA+

CBER chief floats rare dis­ease hub to bet­ter com­mu­ni­cate across cen­ters

11 months ago
FDA+

Cor­rect­ed: Emer­gent sells Bal­ti­more fa­cil­i­ty for $30M

11 months ago
Manufacturing

Ab­b­Vie adds ul­cer­a­tive col­i­tis to Skyrizi la­bel

11 months ago
FDA+

In­ter­na­tion­al so­ci­ety crit­i­cizes Utah law for per­mit­ting un­ap­proved stem cell ther­a­pies

11 months ago
Cell/Gene Tx
FDA+

FDA loosens side ef­fect re­port­ing re­quire­ments for some CAR-T ther­a­pies

11 months ago
Cell/Gene Tx
FDA+

FTC backs plan to tar­get more patent set­tle­ments it sees as an­ti­com­pet­i­tive

11 months ago
FDA+

Te­va and US gov­ern­ment dis­cuss set­tling kick­back law­suit over Co­pax­one

11 months ago
Law

In­tra-Cel­lu­lar re­ports a de­pres­sion win, set­ting up fu­ture com­pe­ti­tion with Ab­b­Vie's Vray­lar

11 months ago
R&D

As it deep­ens im­munol­o­gy bets, Sanofi inks small mol­e­cule pact with Bel­har­ra

11 months ago
Startups
Deals

Mer­ck­'s 21-va­lent pneu­mo­coc­cal vac­cine for adults wins FDA ap­proval

11 months ago
FDA+

GSK read­ies Blenrep's com­mer­cial re-launch in the US, and a push in sec­ond line

11 months ago
R&D

FDA ap­proves en­dome­tri­al can­cer in­di­ca­tions for Keytru­da, Imfinzi

11 months ago
FDA+

Janssen or­dered to pay $150M over false claims around HIV drugs

11 months ago
Law

Am­gen nabs new Blin­cy­to ap­proval for cer­tain type of leukemia

11 months ago
FDA+

J&J ce­ments foot­print in Italy with €580M in in­vest­ments over the next 5 years

11 months ago
R&D
Manufacturing

FDA asks Covid-19 vac­cine mak­ers to in­stead tar­get KP.2 strain for fall sea­son

11 months ago
FDA+
Coronavirus

End­ing 'prod­uct hop­ping' and oth­er patent changes could save US $3B over a decade, CBO says

11 months ago
FDA+
Law

Bris­tol My­er­s' can­cer drug Aug­ty­ro wins new ac­cel­er­at­ed ap­proval in sol­id tu­mors

11 months ago
FDA+

Stake­hold­ers weigh in on po­ten­tial re­forms to FDA ad­vi­so­ry com­mit­tee process

11 months ago
FDA+

Phar­ma in­dus­try prais­es Supreme Court's re­jec­tion of abor­tion pill chal­lenge

11 months ago
FDA+
Law
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