FDA+ channel feed

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

No­var­tis' Tafin­lar/Mekin­ist com­bo scores new in­di­ca­tion in pe­di­atric brain can­cer

3 years ago
Pharma

In re­ver­sal, Sarep­ta to face FDA’s pan­el of out­side ex­perts on Duchenne gene ther­a­py

3 years ago
Cell/Gene Tx

FDA ad­comm votes in fa­vor of Pfiz­er's Covid-19 pill Paxlovid

3 years ago
Pharma

FDA par­tial­ly lifts dos­ing hold on Stoke Ther­a­peu­tic­s' pe­di­atric Dravet syn­drome study

3 years ago
R&D

Ahead of ad­comm for full ap­proval, FDA es­ti­mates Pfiz­er's Covid pill could save 1,500 lives per week

3 years ago
Coronavirus

FDA warns anes­the­si­ol­o­gist for run­ning clin­i­cal in­ves­ti­ga­tions with­out an IND

3 years ago
First page Previous page 58596061626364 Next page Last page
A service from the Financial Times