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

Yesterday

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

2 days ago

House committee advances key PBM bills in step with Senate counterparts

2 days ago

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

2 days ago

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

3 days ago

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

3 days ago

FDA approves Novartis drug for rare blood disorder

3 days ago

FDA sends letter to Novartis over Kymriah manufacturing safety concerns

4 days ago

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

4 days ago

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

5 days ago

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

5 days ago

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

5 days ago

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

Last week

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

Last week

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

Last week

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

Last week

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

Last week

Senate Finance Committee to review federal policies on drug shortages

Last week

Intas Pharmaceuticals' Indian facility hit with FDA warning letter, placed on import alert

Last week

FDA to make decision about Karuna's schizophrenia drug by next September

Last week

FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer

Last week

Aldeyra's dry eye drug gets a rejection from the FDA

Last week

SpringWorks Therapeutics ready to launch newly-approved desmoid tumor treatment after three-month delay

Last week

Marks: FDA open to using single-arm studies for accelerated approval of rare disease gene therapies

Last week

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