FDA+ channel feed

GSK and oth­ers delist Or­ange Book patents af­ter FTC tar­gets pro­tec­tions on in­halers and ep­i­neph­rine in­jec­tors

Last year

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

Last year
Pharma

Bio­phar­ma man­u­fac­tur­ers call for clar­i­ty on FDA's ad­vanced des­ig­na­tion guid­ance 

Last year
Manufacturing

FDA ex­pands la­bel for No­var­tis and Roche's block­buster, con­verts EMD Serono's NSCLC drug to full ap­proval

Last year
Pharma

FDA sets June de­ci­sion dead­line for po­ten­tial full ap­proval, la­bel ex­pan­sion of Sarep­ta’s Duchenne gene ther­a­py

Last year
Cell/Gene Tx

FDA goes af­ter web­sites mar­ket­ing 'u­nap­proved' semaglu­tide, tirzepatide

Last year
Pharma

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

Last year
Pharma

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

Last year
Pharma

FDA com­mis­sion­er hints at car­dio-re­lat­ed la­bel ex­pan­sion for We­govy, full ap­proval for Lil­ly's new Alzheimer's drug

Last year

Eicos Sci­ences wins FDA ap­proval for first se­vere frost­bite treat­ment

Last year
Pharma

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

Last year
Pharma

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

Last year
Pharma

FDA de­lays PDU­FA date for Rock­et’s rare white blood cell dis­or­der gene ther­a­py

Last year
Manufacturing

Organon shelves con­tra­cep­tive with 'nat­u­ral' es­tro­gen

Last year
Pharma

Stake­hold­ers brace for bumps in rare pe­di­atric dis­ease PRV reau­tho­riza­tion

Last year
Pharma

Take­da wins long-await­ed US ap­proval for first oral drug for eosinophilic esophagi­tis

Last year
Pharma

FDA ad­dress­es ex­pand­ed use of da­ta mon­i­tor­ing com­mit­tees in draft guid­ance

Last year
Pharma

FDA fi­nal­izes rule on us­ing mas­ter files in bi­o­log­ics ap­pli­ca­tions

Last year
Pharma

US and EU reg­u­la­tors be­gin of­fer­ing par­al­lel sci­en­tif­ic ad­vice to gener­ic drug­mak­ers

Last year

Af­ter 'mis­lead­ing' in­for­ma­tion de­lays FDA in­spec­tion, Chi­nese API man­u­fac­tur­er hit with an OAI

Last year
Manufacturing

House pass­es ban on use of QALYs in fed­er­al health pro­grams

Last year
Pharma

As­traZeneca CEO calls open­ing IRA drug price of­fer 'rel­a­tive­ly en­cour­ag­ing' in first char­ac­ter­i­za­tion of talks

Last year
Pharma

Catal­ent’s In­di­ana site clos­es out three Form 483s in past two years

Last year
Manufacturing

EMA seeks to ease the reg­u­la­to­ry bur­den on biosim­i­lar de­vel­op­ers, fol­low­ing push by FDA

Last year
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