FDA+ channel feed

FDA+ roundup: Lessons learned from two qual­i­ty rat­ings pi­lots; Ex­pand­ed FDA col­lab with or­gan-on-a-chip com­pa­ny

3 years ago

FDA urges fed­er­al judge to pro­tect abor­tion pill ac­cess

3 years ago

FDA of­fers new draft guid­ance on can­cer drug dose op­ti­miza­tion with over­haul of max­i­mum tol­er­at­ed dose par­a­digm

3 years ago

Biden’s chief sci­ence of­fi­cer for Covid-19 steps down amid dearth of top lead­er­ship

3 years ago

US in­ves­ti­gates po­ten­tial safe­ty sig­nal with Pfiz­er Covid boost­ers

3 years ago
Pharma
Coronavirus

No­vo Nordisk's GLP-1 for Type II di­a­betes ap­proved for first-line treat­ment

3 years ago

As­traZeneca to dis­con­tin­ue rare blood can­cer drug in the US

3 years ago
Pharma

Sun Phar­ma fa­cil­i­ty un­der an im­port alert hand­ed a warn­ing let­ter

3 years ago
Pharma
Manufacturing

As­traZeneca and Avil­lion win ap­proval for new asth­ma res­cue treat­ment in adults

3 years ago
Pharma

Next-gen Covid vac­cines: No more quick vari­ant up­dates and RCTs may be re­quired, CBER leader writes

3 years ago
Coronavirus

ICY­MI: FDA com­mis­sion­er calls for more on­shoring of clin­i­cal tri­als

3 years ago

Pre­ci­sion Bio­Sciences gets pos­i­tive CMC feed­back for al­lo­gene­ic CAR-T can­di­date

3 years ago
Manufacturing

Ei­sai prices Alzheimer's drug at $26,500, be­low part­ner Bio­gen's Aduhelm

3 years ago
Pharma

FDA grants pri­or­i­ty re­views for Pfiz­er's Pre­vnar 20 for kids and Roche lym­phoma can­di­date

3 years ago
Pharma

Break­ing: FDA clears sec­ond Alzheimer's drug in 'foun­da­tion­al spark' for field

3 years ago
R&D
Pharma

While keep­ing eye on snap NASH OK, In­ven­ti­va tests out al­ter­na­tive PhI­II path

3 years ago
R&D

FDA de­ci­sion, launch of gas­troin­testi­nal drug de­layed af­ter ni­trosamine found in com­mer­cial batch­es

3 years ago

Up­dat­ed: Drug­mak­ers ben­e­fit 'sub­stan­tial­ly' from sec­ondary patents on in­halers — study

3 years ago
Pharma

Every drug ap­proved in 2022: A year of few­er new prod­ucts, but gene ther­a­py firsts and new block­busters

3 years ago
R&D
Special

Con­gres­sion­al in­quiry in­to 'high­ly atyp­i­cal' FDA-Bio­gen ties ends with damn­ing re­port, no reper­cus­sions

3 years ago
Pharma

TG cross­es the fin­ish line in MS, turn­ing U2 com­po­nent in­to stand­alone drug for biotech's sec­ond ap­proval

3 years ago

FDA grants ap­peal for Arde­lyx chron­ic kid­ney dis­ease drug af­ter Ju­ly 2021 re­jec­tion

3 years ago
R&D

FDA is­sues warn­ing let­ter to South Amer­i­can in­gre­di­ent man­u­fac­tur­er over da­ta prob­lems

3 years ago
Manufacturing

Ac­er, Re­lief win FDA ap­proval for rare meta­bol­ic dis­ease af­ter clear­ing in­spec­tion hur­dles

3 years ago
Pharma
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