House De­moc­rats push back on Re­pub­li­cans’ drug short­age pro­pos­als dur­ing leg­isla­tive hear­ing

Last year
Pharma
FDA+

CMS re­veals 34 Medicare drugs sub­ject to in­fla­tion re­bates un­der IRA next quar­ter

Last year
Pharma
FDA+

Alex­ion looks to set­tle law­suit over Soliris sales prac­tices for $125M

Last year
Pharma
Law

Eylea drug­mak­er Re­gen­eron launch­es eye dis­ease aware­ness ef­fort with ac­tor and dancer Deb­bie Allen

Last year
Pharma
Marketing

J&J faces South African com­pe­ti­tion probe over high tu­ber­cu­lo­sis drug prices

Last year
Pharma
Law

FTC is­sues pol­i­cy con­demn­ing the im­prop­er list­ing of patents in FDA's Or­ange Book

Last year
Pharma

J&J changes Janssen phar­ma unit name, drops fa­mil­iar cur­sive lo­go in brand up­date

Last year
Pharma
Marketing

Ab­cam founder Jonathan Mil­ner op­pos­es Dana­her buy­out; First Wave tries to find new life in Sanofi drug

Last year
News Briefing
AI

MAPS plans to seek ap­proval of MD­MA-as­sist­ed ther­a­py this year af­ter sec­ond pos­i­tive PhI­II tri­al

Last year
R&D

Bris­tol My­ers cuts mid-stage NASH, an­ti-TIG­IT pro­grams

Last year
R&D

Why End­points is bring­ing a new fo­cus to our man­u­fac­tur­ing cov­er­age

Last year
Editor's note
Manufacturing

Astel­las ear­marks $354.2M for Irish build; Sam­sung Bi­o­log­ics get in­to AD­Cs; Rentschler gets UK fa­cil­i­ty ap­proved

Last year
Manufacturing

Q&A: Lon­za CGT pres­i­dent Daniel Pal­mac­ci talks man­u­fac­tur­ing amid low­er sales out­look

Last year
Cell/Gene Tx
Manufacturing

Ab­b­Vie turns its back on Har­poon’s BC­MA-tar­get­ing mul­ti­ple myelo­ma drug

Last year
Deals
R&D

Mod­er­na cuts four pro­grams in vac­cines, sol­id tu­mors and heart fail­ure as it in­creas­es, pri­or­i­tizes pipeline

Last year
R&D

Flag­ship’s AI uni­corn Gen­er­ate rais­es $273M Se­ries C, as first drug in 17-pro­gram pipeline en­ters the clin­ic

Last year
Financing
AI

Gene ther­a­py biotech Alveo­Gene launch­es with lentivi­ral plat­form for res­pi­ra­to­ry dis­eases

Last year
Startups
R&D

FDA ad­comm votes in fa­vor of Al­ny­lam's new in­di­ca­tion for On­pat­tro

Last year
FDA+

CDER chal­lenges On­copep­tides’ ap­peal over Pepax­to with­draw­al

Last year
Pharma
FDA+

FDA makes some strides in eas­ing US can­cer drug sup­ply short­ages by work­ing with man­u­fac­tur­ers

Last year
FDA+
Manufacturing

HHS says Mer­ck­'s in­ter­pre­ta­tions of IRA 'doom' its le­gal chal­lenge

Last year
Pharma
FDA+

FDA sets spring de­ci­sion date for Madri­gal’s NASH treat­ment, days af­ter com­pa­ny an­nounced new CEO

Last year
R&D
FDA+

Af­ter an $80M Se­ries D raise, Dal­Cor takes an­oth­er shot at a PhI­II my­ocar­dial in­farc­tion tri­al

Last year
Financing
R&D

Rock­et Phar­ma­ceu­ti­cals says FDA agrees to 12-pa­tient study for ac­cel­er­at­ed ap­proval, ex­pects to raise $175M

Last year
Financing
FDA+
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