At two-year fol­low-up, Evrys­di con­tin­ues to show nu­mer­i­cal im­prove­ments in da­ta, Roche says

5 years ago
R&D

FDA cof­fers are tapped for a down pay­ment on a $300M Covid-19 PSA to ‘de­feat de­spair’

5 years ago
FDA+
Coronavirus

Gilead wins a block­buster con­so­la­tion prize with EC, Japan­ese ap­provals for fil­go­tinib — but that bare­ly soft­ens ...

5 years ago
FDA+

Galec­to reaps $64M to bring lead drug across IPF fin­ish line, while mak­ing moves in NASH and be­yond

5 years ago
Financing

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

5 years ago
Pharma
FDA+

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

5 years ago
Financing

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

5 years ago
Peer Review

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

5 years ago
FDA+
Coronavirus

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

5 years ago
Coronavirus

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

5 years ago
Deals

Covid-19 roundup: Mon­cef Slaoui says 'e­nough' af­ter War­ren calls for his fir­ing; Sci­en­tists spot­light role of ...

5 years ago
Coronavirus

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

5 years ago
Pharma

No­vavax teas­es Covid-19 vac­cine tri­al de­sign as it kicks off UK study — US to fol­low next month

5 years ago
Coronavirus

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

5 years ago
Financing
R&D

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the ...

5 years ago
Coronavirus

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

5 years ago
Financing
R&D

News brief­ing: HHS chas­tis­es Eli Lil­ly for end­ing some dis­counts in a pan­dem­ic; Gilead to pay $97 mil­lion to set­tle ...

5 years ago
News Briefing

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

5 years ago
FDA+
Coronavirus

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants ...

5 years ago
Coronavirus

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

5 years ago
Financing

Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from ...

5 years ago
People
Coronavirus

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

5 years ago
FDA+
Coronavirus

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

5 years ago
Startups
Coronavirus

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

5 years ago
Financing
R&D
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