FDA+ channel feed – Endpoints News

FDA+ channel feed

Appeals court rules in favor of FDA regulating certain stem cell clinics more strictly

7 months ago

FDA pledges to take next steps on advisory committee changes

7 months ago

J&J pulls the plug on 340B rebate model changes opposed by government

7 months ago

US government renews threats over J&J's proposed 340B rebate model

7 months ago

FDA approves Dupixent in COPD, opening ‘next chapter’ for Sanofi and Regeneron’s bestseller

7 months ago

FDA approves Bristol Myers and Karuna's schizophrenia drug, in milestone for psychiatry

7 months ago

FDA lifts hold on Biomea’s diabetes trials

7 months ago

AstraZeneca's lung cancer blockbuster Tagrisso wins label expansion in early-stage EGFR patients

7 months ago

Updated: FDA adcomm votes to limit Opdivo, Keytruda use in stomach, esophageal cancers based on key biomarker

7 months ago

Pfizer pulls sickle cell drug from all markets after data review showed rise in deaths and complications

7 months ago

EMA to discuss Pfizer's sickle cell drug Oxbryta after patient deaths

7 months ago

FDA OKs IntraBio's drug less than a week after rare disease's first-ever approval

7 months ago

FDA adcomm will reexamine approval of checkpoint inhibitors in two cancers based on key biomarker

7 months ago

Novo Nordisk CEO skeptical of PBM promises in Senate hearing on weight loss drug prices

7 months ago

House passes reauthorization of rare pediatric voucher program

7 months ago

UCB adds three more FDA approvals to label for potential blockbuster Bimzelx

7 months ago

Sanofi's Sarclisa gets approved as a first-line option for some patients newly diagnosed with multiple myeloma

7 months ago

J&J will defend its proposed 340B changes as US threatens penalties

7 months ago

FDA OKs the first-ever self-administered vaccine, for flu

7 months ago

European regulators reaffirm Apellis’ rejection, add eight positive recommendations

7 months ago

Updated: FDA approves Zevra’s rare disease drug after resubmission

7 months ago

House committee advances PRV reauthorization, but timing on final passage remains 'murky'

7 months ago

FDA inspectors discover trucks carrying torn-up records leaving Indian generics factory

7 months ago

FDA rejects Vanda’s treatment for digestion condition, company rebukes agency's actions

7 months ago

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