FDA+ channel feed – Endpoints News

FDA+ channel feed

Updated: FDA rejects Regeneron's bispecific for lymphoma over confirmatory trial status

Last year

J&J's Actelion buyout pays off again with approval of Opsynvi in pulmonary arterial hypertension

Last year

Esperion eyes new commercial push for cholesterol-lowering drugs after big FDA label expansion

Last year

FDA to delete 'You are not a horse' post and others in ivermectin case settlement

Last year

Senators push HHS on ‘inadequate’ response to Change Healthcare cyberattack

Last year

FDA approves Italfarmaco’s drug Duvyzat for Duchenne muscular dystrophy

Last year

Global AIDS program revived in government spending package as other health riders fall off

Last year

Kentucky is the fourth state to allow insurers to require biosimilar prescriptions before branded versions

Last year

FDA approves Idorsia’s high blood pressure drug for patients who need other options

Last year

When can observational studies support a drug's effectiveness? FDA explains in new draft guidance

Last year

Senators press Department of Defense on overreliance on foreign drug manufacturers

Last year

FDA proposes tightening restrictions on compounding three categories of drugs

Last year

Updated: FDA expands label for nasal spray to treat chronic sinus inflammation

Last year

FDA greenlights Orchard's gene therapy Lenmeldy for rare and fatal disease

Last year

Updated: FDA adcomm backs benefits of Abecma and Carvykti in earlier patients

Last year

Bristol Myers scores accelerated approval in more blood cancers for CAR-T therapy Breyanzi

Last year

FDA lays out cross-agency efforts on regulating AI in medical products

Last year

After years of delay, BeiGene finally lands FDA approval for its PD-1 drug

Last year

FDA adcomm votes in favor of Geron's anemia drug for cancer patients despite questions on risk

Last year

FDA approves Madrigal’s NASH drug, marking the first-ever treatment for the liver disease

Last year

Lawmakers amp up calls for PBM reforms to be included in next week's funding package

Last year

Mirum expands label for rare liver disease drug, serving up more competition for Ipsen's Bylvay

Last year

FDA raises concerns of 'early deaths' in Abecma and Carvykti multiple myeloma trials

Last year

FDA challenges safety, efficacy of Geron's imetelstat ahead of advisory committee meeting

Last year

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