Pan­dem­ic trav­el re­stric­tions force FDA to de­lay a BLA re­view — in­volv­ing a site in­spec­tion in Ko­rea

5 years ago
FDA+

UP­DATE: For­ma takes aim at Agios with new AML com­plete re­mis­sion da­ta

5 years ago
R&D

With FDA de­ci­sion loom­ing, GSK sweet­ens the PD-1 pot for dis­cov­ery part­ner Anap­tys­Bio as Hal Bar­ron moves to guard ...

5 years ago
Deals

Bio­gen chair Ste­lios Pa­padopou­los takes his in­vest­ing ex­pe­ri­ence to the SPAC par­ty, rais­ing $100M for a blank check ...

5 years ago
Financing

No­var­tis suc­ceeds where Alex­ion failed, com­ing up with a win for a prized as­set in a rare kid­ney dis­or­der

5 years ago
R&D

Fi­bro­Gen’s new PhI­II da­ta set it up for quick OK, an­a­lysts say. But can it avoid a black box warn­ing?

5 years ago
R&D

Covid-19 roundup: As­traZeneca's can­di­date could elic­it im­mune re­sponse in old­er pa­tients; The EMA could ap­prove a ...

5 years ago
Coronavirus

What can a biotech en­tre­pre­neur and a top sci­en­tist come up with on a cou­ple of shared flights? Well...

5 years ago
R&D

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

5 years ago
Deals
Cell/Gene Tx

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

5 years ago
R&D

Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

5 years ago
R&D

FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its ...

5 years ago
FDA+
Coronavirus

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

5 years ago
Financing

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred ...

5 years ago
Deals
Cell/Gene Tx

News brief­ing: Gilead com­pletes $21B buy­out of Im­munomedics; In­nate re­ceives $50M mile­stone pay­ment from As­traZeneca

5 years ago
News Briefing

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

5 years ago
R&D

Arndt Rolfs steps aside as Cen­to­gene CEO, with An­drin Os­wald named as his suc­ces­sor; João Sif­fert lands an­oth­er CEO ...

5 years ago
Peer Review

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues ...

5 years ago
Financing

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on ...

5 years ago
Coronavirus

Chi­nese in­vestors wa­ger $105M on an IPO-bound biotech look­ing to push RNAi as main­stream can­cer ther­a­py

5 years ago
Financing
China

In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

5 years ago
People
Pharma

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

5 years ago
FDA+
Coronavirus

FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep ...

5 years ago
Pharma
FDA+

Retrophin beefs up the rare dis­ease drug pipeline with a $517M buy­out deal

5 years ago
Deals
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