FDA adds new 'do not use' note to In­ter­cep­t's Ocali­va la­bel af­ter a slew of side ef­fect re­ports in cir­rho­sis pa­tients

5 years ago
FDA+

FDA steers J&J/Leg­end CAR-T to a quick de­ci­sion as part­ners prep a loom­ing show­down with Bris­tol My­ers, blue­bird

5 years ago
Cell/Gene Tx
FDA+

Look­ing to build new smart cells, Blue­Rock teams with Tim Lu's Sen­ti Bio in 'sec­ond-or­der' en­gi­neer­ing al­liance

5 years ago
Deals
Cell/Gene Tx

US paus­es use of Eli Lil­ly Covid-19 mAb com­bo in six more states due to vari­ants from Brazil, In­dia

5 years ago
Pharma
Coronavirus

Five an­a­lyt­ics firms launch RWE lob­by­ing group to press Con­gress, FDA on guid­ance, Cures 2.0

5 years ago
FDA+

Covid-19 roundup: Pres­i­dent Biden or­ders in­tel­li­gence com­mu­ni­ty to re­dou­ble ef­forts to de­ter­mine if virus orig­i­nat­ed ...

5 years ago
Coronavirus

As FDA clears re­l­u­golix for uter­ine fi­broids, My­ovant, Pfiz­er gear up to take on Ab­b­Vie in com­mer­cial ri­val­ry

5 years ago
Pharma
FDA+

No­vo Hold­ings, Vi­vo lead a record $200M raise for a Sin­ga­pore-based tools play­er with plans for a Boston hub, new ...

5 years ago
Financing
China

A UK an­ti­fun­gal play­er with a Big Phar­ma pedi­gree bags fresh round of cash as it races to­ward late-stage tri­al

5 years ago
Financing

FDA au­tho­rizes Vir-GSK an­ti­body as vari­ants threat­en Eli Lil­ly mAb

5 years ago
R&D
Coronavirus

Mer­ck KGaA draws the cur­tain on newest lipid nanopar­ti­cle for mR­NA vac­cines, tur­bocharg­ing its an­nu­al ca­pac­i­ty

5 years ago
Coronavirus
Manufacturing

Opin­ion: It shouldn’t mat­ter who the FDA com­mis­sion­er is when it comes to con­tro­ver­sial drug ap­proval de­ci­sions

5 years ago
FDA+
Opinion

PureTech's video game for AD­HD gets big Se­ries D fi­nanc­ing; Day One in­creas­es term sheet ahead of ex­pect­ed IPO

5 years ago
News Briefing

Un­der-the-radar NiKang Ther­a­peu­tics bursts on­to the scene with $200M Se­ries C from in­vestors that screams IPO

5 years ago
Financing

‘In­ac­cu­ra­cies’ push FDA to re­verse Trump-era ter­mi­na­tion of its Un­ap­proved Drugs Ini­tia­tive

5 years ago
Pharma
FDA+

Tra­vere takes a hit as FDA staffers shoo off their ac­cel­er­at­ed drug pitch

5 years ago
FDA+

Covid-19 roundup: French in­flu­encers tar­get­ed in mis­in­for­ma­tion cam­paign against Pfiz­er; As­traZeneca and the EU le­gal ...

5 years ago
Coronavirus

Omid Farokhzad’s biotech in­sid­ers SPAC opens the deal win­dow with $200M to play with

5 years ago
Financing

Eight bets in, Spain's Ys­ios of­fi­cial­ly ties a bow around €216M fund

5 years ago
Financing

Tim Lu is ready to take his AI-fo­cused biotech to the next lev­el with first big fundrais­ing round

5 years ago
Financing
AI

Three years af­ter piv­ot­ing out of dis­as­ter, Vec­tura gets a $1.4B pri­vate eq­ui­ty buy­out

5 years ago
Deals

Hunt­ing a T-cell cure for sol­id tu­mors, Rick Klaus­ner’s Lyell steers to Nas­daq — with big dreams and fresh ...

5 years ago
Financing

FDA clos­es the door on EUA re­quests for some fu­ture Covid-19 vac­cines

5 years ago
FDA+
Coronavirus

Deaths of mon­keys spur clin­i­cal hold for rare dis­ease biotech's lead and on­ly drug — and a $95M cash in­fu­sion goes ...

5 years ago
FDA+
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