FDA+ channel feed

PTC finds it­self in quag­mire of reg­u­la­to­ry set­backs, push­es back time­line on PKU treat­ment

Last year
R&D

FDA ques­tions off-tar­get ed­it test­ing on Ver­tex and CRISPR's po­ten­tial sick­le cell gene ther­a­py ahead of ad­comm

Last year
Cell/Gene Tx

Eli Lil­ly’s ul­cer­a­tive col­i­tis drug ap­proved by FDA in crowd­ed mar­ket

Last year
Pharma

Study: On­col­o­gists who take phar­ma mon­ey are more like­ly to pro­vide low-val­ue treat­ments

Last year
Pharma

Law­mak­ers push for faster, con­di­tion­al FDA ap­proval path­way for rare dis­ease drugs

Last year
Pharma

UK reg­u­la­tors warn against fake Ozem­pic and Sax­en­da pens

Last year
Pharma

Eu­ro­pean Com­mis­sion out­lines how coun­tries can share drugs to mit­i­gate short­ages

Last year
Manufacturing

ACIP rec­om­mends rou­tine use of mpox vac­cine for at-risk adults, open­ing the door to po­ten­tial 2024 launch

Last year
Pharma

Re­mote FDA drug in­spec­tions: New draft guid­ance spells out post-pan­dem­ic specifics

Last year
Manufacturing

NIH nom­i­nee Mon­i­ca Bertag­nol­li clears Sen­ate pan­el with bi­par­ti­san sup­port de­spite Sanders’ drug pric­ing qualms

Last year
People
Pharma

FDA ex­pect­ed to de­cide on As­traZeneca's self-ad­min­is­tered flu vac­cine next quar­ter

Last year
Pharma

Sam­sung adds an­oth­er Lu­cen­tis in­ter­change­able biosim­i­lar to the mix

Last year
Pharma

Sanders goes af­ter NIH for grant­i­ng ex­clu­sive patent for po­ten­tial can­cer ther­a­py

Last year
Pharma

Sanofi and Re­gen­eron's block­buster Dupix­ent re­ject­ed by FDA for chron­ic hives con­di­tion

Last year
Pharma

FDA ap­proves first sub­cu­ta­neous ver­sion of block­buster IBD drug in­flix­imab

Last year
Pharma

Pe­di­atric la­bels: FDA ex­pands can­cer and dwarfism drugs from Genen­tech and Bio­Marin

Last year
Pharma

Un­ap­proved us­es of ap­proved drugs: FDA lays out phar­ma con­sid­er­a­tions for in­form­ing providers

Last year
Pharma

Eli Lil­ly re­veals two-year da­ta for ex­per­i­men­tal eczema treat­ment af­ter FDA road­block

Last year
R&D
Pharma

Pfiz­er wins first US ap­proval for pen­tava­lent meningo­coc­cal vac­cine 

Last year
Pharma

House Re­pub­li­cans threat­en sub­poe­na over de­tails of NIH mpox re­search

Last year

RWD and RWE are not the same: FDA lead­ers dis­pel com­mon mis­con­cep­tions in new pa­per

Last year
Pharma

Nec­tar Life­sciences hit with un­ti­tled let­ter over re­peat GMP is­sues at an­timi­cro­bial site

Last year
Manufacturing

Sam­sung's bi­o­log­ics plant in South Ko­rea re­ceives Form 483 over da­ta in­tegri­ty, oth­er ob­ser­va­tions

Last year
Manufacturing

Risk-ben­e­fit de­ter­mi­na­tions: FDA fi­nal­izes long-await­ed guid­ance for drug­mak­ers

Last year
Pharma
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