about the author

Katherine Lewin

News Reporter

klewin@endpointsnews.com

Katherine Lewin joined Endpoints News in 2022. She was the enterprise reporter at the Florida Times-Union before joining Endpoints, and was also a Poynter fellow and Report for America corps member. She graduated from Flagler College with a Bachelor's degree in Journalism and International Studies. When not working, she is surfing or hanging out with her two dogs.

author articles

Ot­su­ka and Lund­beck get FDA nod for schiz­o­phre­nia, bipo­lar dis­or­der in­jec­tion

Last month
Pharma

FDA warns some Il­lu­mi­na DNA se­quenc­ing de­vices could be vul­ner­a­ble to hack­ers

Last month
FDA+
Diagnostics

FDA to re­view Takeda's BLA re­sub­mis­sion for sub­cu­ta­neous UC drug En­tyvio af­ter 2019 re­jec­tion

Last month
Pharma

Pat­tern Bio­science rais­es $28.7M Se­ries C for faster, more ef­fi­cient an­tibi­ot­ic re­sis­tance test

Last month
Financing
Diagnostics

Sang­amo cuts 120 jobs, an­nounces pri­or­i­tized pipeline to ex­tend cash run­way an­oth­er year

Last month
Cell/Gene Tx

Ahead of ad­comm, FDA rais­es con­cerns about plan to ex­pand Lyn­parza­'s use in prostate can­cer

Last month
Pharma
FDA+

Finch Ther­a­peu­tics brings on new CEO, CFO af­ter Jan­u­ary lay­offs and scrap­ping a PhI­II tri­al

Last month
Startups

Enan­ta sells off over 50% of roy­al­ty pay­ments from Mavyret in ex­change for $200M

Last month
Deals
Pharma

Flori­da-based biotech with ap­proved car­dio­vas­cu­lar ther­a­py moves to go pub­lic via SPAC

Last month
Deals
R&D

Boehringer In­gel­heim kicks off €350M R&D cen­ter in Ger­many

Last month
R&D
Pharma

FDA lifts near­ly two-year hold on MaaT Phar­ma's mi­cro­bio­me ther­a­py, opens door to PhI­II

Last month
FDA+

FDA push­es back PDU­FA date for Dai­ichi's AML drug quizar­tinib over REMS up­dates

Last month
FDA+

Astel­las and Twist team up in an­ti­bod­ies; FDA asks DBV for an ad­di­tion­al safe­ty study in peanut al­ler­gy patch

Last month
News Briefing

Karyopharm stock drops af­ter in­hibitor's PhI da­ta show low­er dose not as ef­fec­tive: #AACR23

Last month
R&D

KRAS, one of can­cer’s tough­est tar­gets, sees a surge of new ther­a­pies try­ing to lim­it side ef­fects: #AACR23

Last month
R&D

Roche's com­bo ther­a­py re­duces risk of liv­er can­cer re­turn­ing but rais­es safe­ty ques­tions: #AACR23

Last month
R&D

Mer­ck­'s Keytru­da-chemo re­duces risk of death from bil­iary tract can­cer by 17%: #AACR23

Last month
R&D

Supreme Court steps in to stay Texas court's rul­ing on mifepri­s­tone

Last month
Pharma

Pfiz­er teams up with Sinopharm to mar­ket 12 new drugs in Chi­na — re­port

Last month
Pharma

Ghana ap­proves Ox­ford Uni­ver­si­ty's malar­ia vac­cine for chil­dren

Last month
FDA+

Astel­las takes $435M+ write­down on Evren­zo, hear­ing loss can­di­date and T cell ther­a­py deal

Last month
Deals
Pharma

Up­dat­ed: Mod­er­na: Not enough flu cas­es in PhI­II tri­al yet to tell ef­fi­ca­cy

Last month
R&D

ARCH-backed HI-Bio touts ear­ly da­ta from two tri­als for rare kid­ney dis­ease

Last month
R&D

Judge or­ders Mer­ck to hand over ad­verse events data­base in Gar­dasil law­suit

Last month
Pharma
Law
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