How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

4 years ago
R&D
FDA+

Af­ter re­fut­ing a sup­posed da­ta leak as 'fal­si­fied', Ole­ma re­veals first clin­i­cal da­ta for lead pro­gram — shares ...

4 years ago
R&D

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

4 years ago
Publisher's note

Af­ter Big Phar­ma sparked in­ter­est in the US, Ablaze looks to bring ra­dio­phar­ma­ceu­ti­cals over­seas

4 years ago
Financing
Startups

Covid-19 roundup: As­pen to pro­duce gener­ic J&J vac­cine for Africa; First boost­ers for un­der-18-year-olds could come ...

4 years ago
Coronavirus

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

4 years ago
R&D

Chi­na’s top mR­NA con­tender is ready to go. And Soft­Bank just led a cash in­fu­sion push­ing it over the $1B line

4 years ago
Financing
China

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

4 years ago
Pharma
Marketing

Nev­er too late: For­bion pitch­es $100M SPAC; Kro­nos Bio re­leas­es ear­ly in­ter­im da­ta on CDK9 in­hibitor

4 years ago
News Briefing

Look­ing past Big Phar­ma ri­vals, Blue­print buys a pre­clin­i­cal biotech for $250M+

4 years ago
Deals

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

4 years ago
Financing
Cell/Gene Tx

As Bob Langer biotech's lead cell ther­a­py re­mains on FDA hold, re­searchers find 'un­ex­pect­ed' fi­bro­sis

4 years ago
Cell/Gene Tx

More man­u­fac­tur­ing is­sues: Fen­nec preps for sec­ond CRL for po­ten­tial hear­ing loss drug

4 years ago
Pharma
FDA+

Biotech bil­lion­aire Róbert Wess­man en­gi­neers $450M deal for Alvo­gen sub­sidiaries

4 years ago
Deals

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

4 years ago
FDA+
Coronavirus

Amid JAK de­ba­cle, Bris­tol My­ers set­tles in for FDA's long re­view of po­ten­tial first TYK2 drug

4 years ago
FDA+

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

4 years ago
FDA+
Coronavirus

Covid-19 roundup: As Omi­cron spreads, African biotech re­port­ed­ly close to re­pro­duc­ing Mod­er­na's vac­cine, while WHO ...

4 years ago
Coronavirus

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

4 years ago

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

4 years ago
Financing

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral ...

4 years ago
Weekly

Mer­ck shares slide as re­sponse to its oral Covid an­tivi­ral plunges on lat­est up­date ahead of ad­comm

4 years ago
FDA+

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so ...

4 years ago
Bioregnum
Cell/Gene Tx

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na ...

4 years ago
Coronavirus
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