FDA+ channel feed – Endpoints News

FDA+ channel feed

House passes sweeping healthcare price transparency reforms, reining in PBM practices

Last year

FDA establishes new advisory committee for genetic metabolic disease treatments

Last year

FDA rolls out new draft guidance on advanced manufacturing tech

Last year

FDA sets late 2024 decision deadline for Pfizer’s 'pan-hemophilia' drug: #ASH23

Last year

Bipartisan House bill seeks to boost pediatric drug development via new FDA penalties for noncompliance

Last year

ICER unveils latest report on 'unsupported' drug price increases

Last year

FDA approves two gene therapies for sickle cell disease, including first that uses CRISPR

Last year

Biden proposal on 'march-in' rights would have limited effect on current drug costs, critics say

Last year

House committee advances key PBM bills in step with Senate counterparts

Last year

Biden administration lays foundation for use of march-in rights as it talks up drug price goals

Last year

FDA asks for more data from Optinose, extends review time for nasal spray

Last year

Pfizer plans to pull out of BIO, following moves by other large drugmakers to reduce lobbying footprint

Last year

FDA approves Novartis drug for rare blood disorder

Last year

FDA sends letter to Novartis over Kymriah manufacturing safety concerns

Last year

The politics behind drug shortages: Senators talk issues with generics market, CMS payments

Last year

Roche's BTK inhibitor put on partial hold over concerns about potential liver injury

Last year

House committee investigates FDA’s handling of common nasal decongestant as efficacy questions loom

Last year

FDA approves Lilly’s BTK inhibitor Jaypirca for two more blood cancers

Last year

Samsung Bioepis strikes deal for Stelara biosimilar, but launch likely won't come in time for an IRA exemption

Last year

Apellis' eye disease drug gets safety label update for rare inflammation side effect

Last year

More companies need to set diversity enrollment goals in cancer trials, FDA says

Last year

FDA ships Form 483 to generic drug giant Dr. Reddy’s due to equipment issues, other observations

Last year

Clinicians say benefits of CAR-T continue to outweigh risk of T-cell malignancies

Last year

Senate Finance Committee to review federal policies on drug shortages

Last year

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