FDA+ channel feed

FDA cites ‘de­fi­cien­cies’ in As­cendis’ ap­pli­ca­tion for parathy­roid drug, jeop­ar­diz­ing po­ten­tial ap­proval

3 years ago

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

3 years ago
R&D

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

3 years ago
Pharma
Marketing

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

3 years ago

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

3 years ago

Ot­su­ka, Lund­beck eye Alzheimer's in­di­ca­tion in FDA ad­comm for Rex­ul­ti la­bel ex­pan­sion

3 years ago
Pharma

Blue­bird to miss Q1 dead­line for lo­vo-cel fil­ing, shares sliced

3 years ago

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

3 years ago
Pharma
Marketing

FDA lifts par­tial hold on Blue­print­'s CDK2 in­hibitor

3 years ago

House com­mit­tee chair re­quests in­fo from FDA on fund­ing for tri­als in­volv­ing 'vi­ral ma­nip­u­la­tion'

3 years ago
Law

FDA plans up­com­ing ad­comms for OTC con­tra­cep­tive, ep­i­neph­rine nasal spray, Intar­ci­a's last shot

3 years ago

House com­mit­tee to in­ves­ti­gate FDA's re­sponse to on­go­ing drug short­ages

3 years ago
Pharma
Manufacturing

Brain­Storm gets FDA ad­comm for ALS drug af­ter failed tri­al and RTF

3 years ago
R&D

Up­dat­ed: FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

3 years ago
R&D

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

3 years ago
Pharma

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

3 years ago
Pharma

FDA ap­proves Cidara's Rez­za­yo as an­ti­fun­gal treat­ment for can­didemia and in­va­sive can­didi­a­sis

3 years ago
R&D

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

3 years ago
Pharma

In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

3 years ago
Pharma

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

3 years ago
R&D
Pharma

FDA+ roundup: Leg­isla­tive asks for 2024 fo­cus on more au­thor­i­ties, gener­ic drug com­pe­ti­tion

3 years ago

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

3 years ago
Manufacturing

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

3 years ago
R&D

GAO on com­bo prod­uct patents: Stake­hold­ers split on need for Or­ange Book tweaks

3 years ago
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