One of Glax­o­SmithK­line's top can­cer drug prospects goes down in 3rd straight set­back, leav­ing a $4B deal on life ...

4 years ago
R&D

PDU­FA VII: What's new, and what's sig­nif­i­cant in the next user fee deal

4 years ago
FDA+

KalVista clears in­ter­na­tion­al reg­u­la­to­ry hur­dles on HAE tri­al; Elix­iron rais­es $27M in Se­ries A

4 years ago
News Briefing

Cap­ping AAV dose? Tweak­ing gene ther­a­py tri­als? New an­i­mal mod­els? FDA pos­es far-reach­ing ques­tions for ex­perts

4 years ago
Cell/Gene Tx
FDA+

Gilead, Re­gen­eron, As­traZeneca and more en­cour­age FDA to ex­pand pa­tient re­port­ed out­come guid­ance

4 years ago
FDA+

Genevant scores with Take­da again as LNPs con­tin­ue to at­tract in­ter­est for RNA ther­a­py

4 years ago
Deals

Pfiz­er earns long-await­ed full FDA nod for Covid-19 vac­cine, a hope­ful aid in US cam­paign

4 years ago
FDA+
Coronavirus

Pfiz­er doles out $2.3B for blood can­cer play­er to flesh out its end-of-decade on­col­o­gy port­fo­lio

4 years ago
Deals

RA Cap­i­tal aims to take pre­clin­i­cal biotech to Nas­daq as Tyra files S-1 dur­ing sum­mer lull

4 years ago
Financing

Covid-19 roundup: The FDA has re­it­er­at­ed its warn­ing against par­a­site pre­ven­tion drug in­tend­ed for an­i­mals; Mod­er­na ...

4 years ago
Coronavirus

De­lay­ing the in­evitable? Ax­some says FDA re­view go­ing be­yond PDU­FA date

4 years ago
Pharma
FDA+

An­ti-ag­ing re­search foun­da­tion sacks CSO Aubrey de Grey for dis­rupt­ing sex­u­al ha­rass­ment probe

4 years ago
People

Promi­nent MIT sci­en­tist, biotech founder David Saba­ti­ni is thrown out of the White­head and HH­MI fol­low­ing sex­u­al ...

4 years ago
People

Vac­cine man­dates, bio­phar­ma edi­tion; Alzheimer’s rip­ple ef­fect; Change of guard at J&J; and more

4 years ago
Weekly

In­sil­i­co finds a new part­ner for AI drug dis­cov­ery; EU launch­es Il­lu­mi­na probe af­ter Grail merg­er close

4 years ago
News Briefing

Covid-19 roundup: US in­ves­ti­gat­ing more my­ocardi­tis cas­es linked to Mod­er­na vac­cine; UK ap­proves Re­gen­eron mAb

4 years ago
Coronavirus

Feng Zhang un­veils a new tech­nol­o­gy to po­ten­tial­ly de­liv­er mR­NA, gene ther­a­py, CRISPR and more

4 years ago
People
Discovery

No­vavax grabs an­oth­er CFO while Pat Cotro­neo re­tires from Fi­bro­Gen; Eli Lil­ly re­assem­bles key staff af­ter ...

4 years ago
Peer Review

While fig­ur­ing out post-CRL fu­ture for rox­adu­s­tat, Fi­bro­Gen cel­e­brates Eu­rope OK with Astel­las

4 years ago
FDA+

As­traZeneca says mon­o­clon­al an­ti­body com­bo is 77% ef­fec­tive at pre­vent­ing Covid-19

4 years ago
Coronavirus

FDA grants hear­ing to dis­cuss with­draw­al of con­tentious preterm birth drug Mak­e­na

4 years ago
FDA+

Court up­holds Ab­b­Vie's patents on block­buster can­cer drug Im­bru­vi­ca, gener­ics un­like­ly un­til 2032

4 years ago
Pharma

House com­mit­tee ques­tions Eli Lil­ly, Sanofi and No­vo Nordisk as in­sulin prices re­main 'u­nac­cept­ably high'

4 years ago
Pharma

As­traZeneca cuts PhI­II ALS study af­ter Alex­ion's Ul­tomiris shows 'lack of ef­fi­ca­cy'

4 years ago
R&D
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