about the author

Lia DeGroot

ldegroot@endpointsnews.com

author articles

Ap­peals court re­vives suit against Sanofi's Gen­zyme over ac­cess to Fab­ry dis­ease drug

Last year
Manufacturing
Law

EMA pre­pares for changes to non-in­fe­ri­or­i­ty, equiv­a­lence study guid­ance

Last year
Pharma
FDA+

Es­hoo calls out FDA for miss­ing dead­line on di­ver­si­ty ac­tion plan guid­ance

Last year
Pharma
FDA+

Marks re­hash­es Covid-19 ap­proval time­line, de­fends vac­cines for chil­dren at hear­ing

Last year
Pharma
FDA+

Eicos Sci­ences wins FDA ap­proval for first se­vere frost­bite treat­ment

Last year
Pharma
FDA+

Biden ad­min­is­tra­tion tar­gets GPOs, whole­salers in re­quest for in­for­ma­tion on gener­ic short­ages

Last year
Pharma
FDA+

FDA ap­proves Ipsen’s Onivyde as first-line treat­ment for type of pan­cre­at­ic can­cer

Last year
Pharma
FDA+

Stake­hold­ers brace for bumps in rare pe­di­atric dis­ease PRV reau­tho­riza­tion

Last year
Pharma
FDA+

FDA ad­dress­es ex­pand­ed use of da­ta mon­i­tor­ing com­mit­tees in draft guid­ance

Last year
Pharma
FDA+

FDA fi­nal­izes rule on us­ing mas­ter files in bi­o­log­ics ap­pli­ca­tions

Last year
Pharma
FDA+

House pass­es ban on use of QALYs in fed­er­al health pro­grams

Last year
Pharma
FDA+

House com­mit­tee ad­vances an­oth­er PBM re­form bill that would ban spread pric­ing

Last year
Pharma
FDA+

Law­mak­ers hold FDA for­eign in­spec­tion prac­tices un­der mi­cro­scope at hear­ing with­out agency at­ten­dance

Last year
Pharma
FDA+

Van­da takes is­sue with FDA's re­lay of de­fi­cien­cies for new Het­lioz in­di­ca­tion

Last year
Pharma
FDA+

Mak­ers of block­buster weight loss drugs are us­ing 'patent thick­et­s' to pro­tect prod­ucts, Har­vard study claims

Last year
Pharma
FDA+

For­mer FDA com­mis­sion­ers urge SCO­TUS to pre­serve agency’s reg­u­la­tions of abor­tion pill

Last year
Pharma
FDA+

Rul­ing in SCO­TUS mifepri­s­tone case could lead to end­less lit­i­ga­tion, in­dus­try says

Last year
Pharma
FDA+

Sen­a­tor turns up heat on in­haler man­u­fac­tur­ers to re­move im­prop­er­ly list­ed Or­ange Book patents

Last year
Pharma
FDA+

FDA up­dates draft guid­ance on race and eth­nic­i­ty re­port­ing in clin­i­cal tri­als

Last year
FDA+

Com­pe­ti­tion en­force­ment led to fair­er prices, in­no­v­a­tive prod­ucts — EC re­port

Last year
Pharma
FDA+

As PBMs face threats in Wash­ing­ton, in­dus­try trade group poured mil­lions more in­to lob­by­ing

Last year
Pharma
FDA+

‘I think we will have the votes’: Sanders gears up to sub­poe­na CEOs of J&J, Mer­ck to tes­ti­fy on drug prices

Last year
Pharma
FDA+

Bi­par­ti­san group of law­mak­ers seeks to reign in phar­ma patent thick­ets with new bill

Last year
Pharma
FDA+

De­San­tis, John­son raise flags around Covid boost­ers as FDA main­tains that they're safe and ef­fec­tive

Last year
Pharma
FDA+
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