FDA+ channel feed

Chi­na green­lights home­grown pneu­mo­coc­cal, HPV vac­cines for the mar­ket — break­ing grips by Pfiz­er, Mer­ck

6 years ago
China

Savara gets FDA break­through sta­tus de­spite large, late-stage fail­ure

6 years ago
R&D

As Bris­tol-My­ers, Pfiz­er bat­tle copy­cat chal­lengers in court, FDA ap­proves gener­ics for block­buster Eliquis

6 years ago

In­tra-Cel­lu­lar's check­ered de­vel­op­men­tal path ends in schiz­o­phre­nia ap­proval, shares sky­rock­et

6 years ago

FDA slams GSK's month­ly HIV in­jectable with CRL, cit­ing man­u­fac­tur­ing is­sues

6 years ago

EMA los­es more than 100 staffers in move to Am­s­ter­dam

6 years ago

Ei­sai scores an FDA ap­proval for a home­grown sleep drug

6 years ago
R&D

Why wait? The FDA stamps an ul­tra-fast OK on a HER2+ drug ex­pect­ed to cre­ate As­traZeneca's next block­buster fran­chise

6 years ago

As Con­go Ebo­la out­break fes­ters, FDA ap­proves first vac­cine to com­bat dead­ly virus

6 years ago

FDA drafts guid­ance on demon­strat­ing sub­stan­tial ev­i­dence of ef­fec­tive­ness

6 years ago

Seat­tle Ge­net­ics gets ready to launch its sec­ond ADC af­ter scor­ing blad­der can­cer OK with part­ner Astel­las

6 years ago
R&D

No OS ben­e­fit? No prob­lem. FDA pan­el backs use of Lyn­parza in pan­cre­at­ic can­cer

6 years ago

FDA sur­vey finds Amer­i­cans don’t re­al­ly un­der­stand drug ap­provals

6 years ago

FDA’s in-house re­view of­fers bleak as­sess­ment of Epizyme’s tazeme­to­stat — but win or lose this can­cer drug may still have a fu­ture

6 years ago
R&D

In crowd­ed prostate can­cer mar­ket, Pfiz­er's Xtan­di notch­es third ap­proval for use in ear­li­er stage of dis­ease

6 years ago
R&D

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

6 years ago
Pharma

FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

6 years ago

What's next for Sarep­ta? A third DMD ap­proval, an­a­lysts pre­dict

6 years ago

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

6 years ago
R&D

Stephen Hahn con­firmed as new FDA chief

6 years ago

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

6 years ago

For­eign drug in­spec­tions de­cline as FDA hir­ing strug­gles con­tin­ue

6 years ago

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

6 years ago
People

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

6 years ago
R&D
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