FDA+ channel feed

FDA squash­es ac­cel­er­at­ed hopes for Eli Lil­ly’s Alzheimer’s drug as agency asks for more da­ta

3 years ago
R&D
Pharma

New clin­i­cal tri­al sys­tem to soon be­come manda­to­ry in Eu­rope

3 years ago
Pharma

Rep. Frank Pal­lone wants FDA and NIH to act on phar­ma's non­com­pli­ance with tri­al records law

3 years ago

By sum­mer sol­stice, we'll know the fate of In­ter­cep­t's NASH drug

3 years ago
Pharma

Drug­mak­ers seek tweaks to FDA guid­ance on mea­sur­ing de­vel­op­ment in pe­di­atric tri­als

3 years ago
R&D

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
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