FDA+ channel feed

FDA to im­port ver­sions of com­mon can­cer drug to al­le­vi­ate short­age

18 hours ago
Pharma
Manufacturing

Up­dat­ed: FDA pulls paid Ei­sai con­sul­tant from tem­po­rary role on ad­comm re­view­ing Ei­sai's new Alzheimer's drug

21 hours ago

As­traZeneca moves ear­ly for full ap­proval with an­ti­co­ag­u­lant re­ver­sal drug An­dexxa af­ter pos­i­tive PhIV da­ta

Yesterday
R&D

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

4 days ago
R&D

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

5 days ago
Pharma

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

5 days ago
Pharma
Manufacturing

FDA warns about com­pound­ed semaglu­tide-based drugs

5 days ago
Pharma
Manufacturing

FDA in­spec­tion of Chi­na-based site mak­ing Co­herus' po­ten­tial new can­cer drug ends with three ob­ser­va­tions

5 days ago
China

Clin­i­cal hold for Pep­Gen's my­oton­ic dy­s­tro­phy pro­gram halts march to the clin­ic

6 days ago

FDA in­spec­tion of UCB fa­cil­i­ty in Bel­gium finds sev­er­al qual­i­ty is­sues

6 days ago
Manufacturing

A decade in the mak­ing: FDA pro­pos­es new, easy-to-read pa­tient med­ica­tion guide

6 days ago

Eli Lil­ly set­tles in­sulin pric­ing law­suit for $13.5M, month­ly out-of-pock­et com­mit­ment

6 days ago
Pharma

EU com­mit­tee like­ly to rec­om­mend against ap­prov­ing Amy­lyx ALS drug, com­pa­ny says

Last week
R&D
Pharma

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

Last week
Pharma

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Last week
R&D

In 2023, FDA ap­proves far few­er first gener­ic drugs than in re­cent years

Last week

More than a year af­ter its emer­gency au­tho­riza­tion, FDA ful­ly ap­proves Pfiz­er's Covid pill Paxlovid for adults

Last week
Coronavirus

Gen­er­al­ly ac­cept­ed sci­en­tif­ic knowl­edge: FDA ex­plains how it ap­plies to non­clin­i­cal da­ta in drug apps

Last week

Com­pa­nies ask FDA for reg­u­la­tion, im­prove­ment of da­ta col­lec­tion from dig­i­tal health de­vices

Last week
Pharma

FDA warns Sure-BioChem over qual­i­ty and da­ta is­sues

Last week
Pharma
Manufacturing

FDA grants an ex­pand­ed Ay­vak­it la­bel to Blue­print Med­i­cines

Last week

FDA ap­proves an­oth­er new type of opi­oid over­dose an­ti­dote nasal spray

2 weeks ago

Gov­ern­ment-backed pi­lots in­ves­ti­gate how tech can bet­ter se­cure the drug sup­ply chain

2 weeks ago
Pharma
Manufacturing

FDA plans to on­ly is­sue pe­di­atric ex­clu­siv­i­ty for new stud­ies — not just those re­quired un­der PREA

2 weeks ago
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