Rock­et Phar­ma­ceu­ti­cals says FDA agrees to 12-pa­tient study for ac­cel­er­at­ed ap­proval, ex­pects to raise $175M

Last year
Financing
FDA+

Roy­al­ty Phar­ma ex­ecs shed light on strat­e­gy be­hind their first gene ther­a­py deal

Last year
Deals
Cell/Gene Tx

White House warns over lack­lus­ter FDA fund­ing in­crease in in­com­ing ap­pro­pri­a­tions bill

Last year
FDA+
Law

MaaT Phar­ma and CD­MO Skyephar­ma un­veil be­spoke, and po­ten­tial­ly largest, mi­cro­bio­me fa­cil­i­ty in Eu­rope

Last year
R&D
Manufacturing

Sor­ren­to goes to Chi­na with Covid drug; Vista­gen touts ear­ly ef­fi­ca­cy da­ta on PMDD nasal spray

Last year
News Briefing

Sanofi en­lists rap­per and ac­tor Ice-T for edgy flu cam­paign warn­ing se­niors of risks and com­pli­ca­tions

Last year
Pharma
Marketing

Ex­clu­sive: Phar­ma­cy ad­her­ence start­up Sem­pre Health rais­es $20M

Last year
Financing
Startups

Neu­ro­crine plots 2024 fil­ing for rare dis­ease drug af­ter 'solid' PhI­II win

Last year
R&D

Eiger ends PhI­II he­pati­tis delta tri­al over safe­ty con­cerns — and the search for treat­ment part­ner

Last year
R&D

Mod­er­na CEO shares bold new vi­sion: 15 new prod­ucts and 50 new clin­i­cal can­di­dates in five years

Last year
R&D

Mironid reach­es $43.7M to date in Se­ries A ex­ten­sion to fund kid­ney dis­ease treat­ment stud­ies

Last year
Financing
R&D

CDC pan­el rec­om­mends up­dat­ed Covid boost­ers for peo­ple 6 months and old­er

Last year
Pharma
FDA+

'A done deal': FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly against ef­fi­ca­cy da­ta for OTC nasal de­con­ges­tant

Last year
Pharma
FDA+

Am­gen's Leah Christl makes the case to keep the in­ter­change­abil­i­ty des­ig­na­tion for biosim­i­lars

Last year
FDA+

FDA slaps CVS, Wal­greens and oth­ers with warn­ing let­ters for un­ap­proved eye treat­ments

Last year
Pharma
FDA+

Wal­greens part­ners with a pri­ma­ry care tech start­up to pro­vide new ways to pay for med­ical care

Last year
Health Tech

As­traZeneca, Am­gen de­but new Tezspire mar­ket­ing dur­ing Sep­tem­ber asth­ma ‘peak week’

Last year
Pharma
Marketing

Mar­ket­ingRx roundup: Bris­tol My­ers re-ups cross coun­try cy­cling fundrais­er; Pfiz­er em­ploy­ees share mi­graine ...

Last year
Pharma
Marketing

No­var­tis is­sues vol­un­tary re­call of oral cy­closporine Sandim­mune due to crys­tal­liza­tion con­cerns

Last year
FDA+
Manufacturing

WCLC roundup: As­traZeneca, Am­gen, J&J and Hutchmed tout new com­bi­na­tion or con­fir­ma­to­ry da­ta

Last year
R&D
Pharma

Roche to re­file sub­cu­ta­neous Tecen­triq ap­pli­ca­tion with FDA be­fore year’s end on the back of man­u­fac­tur­ing tweaks

Last year
FDA+
Manufacturing

Ex­elix­is li­cens­es small mol­e­cule from In­sil­i­co for $80M up­front; Ver­tex buys GPCR from Septer­na

Last year
Deals

Aval­on's lat­est biotech clos­es $58M round as it pur­sues treat­ments for au­toim­mune brain con­di­tions

Last year
Financing

Ahead of ad­comm, FDA ques­tions ef­fi­ca­cy of Al­ny­lam's patisir­an in dis­abling rare con­di­tion AT­TR-CM

Last year
R&D
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