FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

4 years ago
Coronavirus

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

4 years ago
Deals

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

4 years ago
R&D
FDA+

Backed by Eli Cas­din, a DNA syn­the­sis com­pa­ny gets a big Se­ries C ahead of its first prod­uct launch

4 years ago
Financing

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

4 years ago
Financing

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

4 years ago
FDA+

Covid-19 roundup: Mod­er­na says vac­cine pro­duces 'strong' re­sponse in 5- to 11-year-olds; As­pen Phar­ma­care plans to up ...

4 years ago
Coronavirus

Av­enue Ther­a­peu­tics lands an FDA ad­comm for trou­bled flag­ship drug; FDA ap­proves eye in­jec­tion treat­ment for flu­id ...

4 years ago
News Briefing

Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

4 years ago
Pharma
Cell/Gene Tx

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

4 years ago
Pharma

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

4 years ago
Pharma
FDA+

En­do taps bent veg­gie in first Xi­aflex brand cam­paign for Pey­ronie's dis­ease curved erec­tion con­di­tion

4 years ago
Marketing

Mer­ck­'s ex­per­i­men­tal HIV drug is­la­travir hits with a PhI­II com­bo win and FDA fil­ing plans

4 years ago
R&D

A transat­lantic biotech flags a painful PhI­II can­cer flop, wav­ing a white flag

4 years ago
R&D

An­oth­er NASH play­er re­treats from bat­tered field af­ter tox­i­col­o­gy study flags po­ten­tial de­lay

4 years ago
R&D

Just as first Lu­cen­tis biosim­i­lar wins ap­proval, Roche snags an OK for an eas­i­er route of ad­min­is­tra­tion

4 years ago
FDA+

Sanofi, Re­gen­eron gear up for new Dupix­ent fil­ing af­ter clear­ing sec­ond PhI­II for eosinophilic esophagi­tis

4 years ago
R&D
Pharma

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

4 years ago
Deals

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

4 years ago
R&D

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and ...

4 years ago
Weekly

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

4 years ago
Financing

A new Treg play­er emerges with $46M and back­ing from Take­da

4 years ago
Financing
Startups

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

4 years ago
Pharma
FDA+

Oc­u­lar Ther­a­peu­tix ham­mered by a PhII fail­ure in dry eye dis­ease — shares tank

4 years ago
R&D
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