about the author

Lia DeGroot

ldegroot@endpointsnews.com

author articles

Ken­tucky is the fourth state to al­low in­sur­ers to re­quire biosim­i­lar pre­scrip­tions be­fore brand­ed ver­sions

Last year
Pharma
FDA+

No­vo Nordisk bol­sters op­er­a­tions in Chi­na with $556M ex­pan­sion project

Last year
China
Pharma

FDA pro­pos­es tight­en­ing re­stric­tions on com­pound­ing three cat­e­gories of drugs

Last year
Pharma
FDA+

FDA lays out cross-agency ef­forts on reg­u­lat­ing AI in med­ical prod­ucts

Last year
AI
Pharma

Law­mak­ers amp up calls for PBM re­forms to be in­clud­ed in next week's fund­ing pack­age

Last year
Pharma
FDA+

US spent $3B on DMD treat­ments as con­fir­ma­to­ry stud­ies still un­der­way, JA­MA pa­per says

Last year
Pharma
FDA+

Biden ad­min­is­tra­tion pro­pos­es fund­ing bump for FDA, nix­ing in­ter­change­abil­i­ty re­quire­ment

Last year
Pharma
FDA+

Phar­ma bris­tles at Biden’s call to ex­pand IRA ne­go­ti­a­tions at State of the Union

Last year
Pharma
FDA+

Bris­tol My­ers nabs ap­proval for Op­di­vo com­bo as first-line blad­der can­cer treat­ment

Last year
R&D
Pharma

FDA sees suc­cess in mod­el-in­formed drug de­vel­op­ment pi­lot

Last year
Pharma
FDA+

FDA faces flat­lined bud­get as clock ticks for Con­gress to pass gov­ern­ment fund­ing

Last year
Pharma
FDA+

Eu­ro­pean Com­mis­sion spells out new pro­pos­als for health tech­nol­o­gy as­sess­ments

Last year
Pharma
FDA+

FDA de­nies hear­ing to Van­da on jet lag in­di­ca­tion for sleep dis­or­der drug

Last year
Pharma
FDA+

J&J's Janssen nabs new in­di­ca­tion, full ap­proval for can­cer drug Ry­bre­vant

Last year
R&D
FDA+

FDA di­rects spon­sors to keep in­formed con­sent in­fo con­cise, tai­lored to par­tic­i­pants

Last year
FDA+

GAO di­rects ARPA-H to fi­nal­ize plan for han­dling du­pli­cate re­search

Last year
R&D
Pharma

Biden ad­min­is­tra­tion in­vests $48M in AI/ML plat­form to iden­ti­fy rare dis­ease drugs

Last year
AI
Pharma

Califf lays out drug short­age land­scape, talks post-mar­ket da­ta col­lec­tion for ac­cel­er­at­ed ap­provals

Last year
Pharma
FDA+

DOJ sub­poe­nas Bio­Marin over spon­sored test­ing pro­gram for rare dis­ease drugs

Last year
Pharma
FDA+

FDA of­fi­cials, drug de­vel­op­ers dis­cuss how to stream­line safe­ty mon­i­tor­ing for bi­o­log­ics

Last year
Pharma
FDA+

FDA de­clines to is­sue fines for non­com­pli­ant tri­al re­port­ing

Last year
Pharma
FDA+

House Dems seek brief­in­gs with Pfiz­er, San­doz and Te­va on on­go­ing drug short­ages

Last year
Pharma
FDA+

Unit­ed Ther­a­peu­tics sues FDA over han­dling of Liq­uidia’s new drug ap­pli­ca­tion for tre­pros­tinil

Last year
Pharma
FDA+

SCO­TUS jus­tices hint at un­cer­tain fu­ture of Chevron doc­trine in tan­gen­tial case

Last year
FDA+
Law
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