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FDA, pancreatic cancer and expanded access

FDA expands access to pancreatic cancer drug helping patients like Ben Sasse

The Food and Drug Administration said it will allow some pancreatic cancer patients to receive access to a promising drug, even before it is officially approved for use.

· 17h · on MSN

FDA authorizes early access for experimental pancreatic cancer pill

· 21h · on MSN

FDA green lights early access to pancreatic cancer drug, daraxonrasib

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For pancreatic cancer, the FDA grants early access to the experimental drug daraxonrasib

Former U.S. Sen. Ben Sasse, R-Neb., is among those already being treated with the experimental pancreatic cancer drug.

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FDA expands access to drug helping pancreatic cancer patients

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Revolution Medicines wins FDA nod to provide early access to cancer therapy

FDA, agitation and Alzheimer's

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FDA approves 1st non-antipsychotic medication for agitation in Alzheimer's disease

The Food and Drug Administration (FDA) approved the drug Auvelity this week for the treatment of agitation in adults with Alzheimer's dementia.

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Axsome Therapeutics Announces FDA Approval of AUVELITY® (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer’s Disease

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US FDA approves Axsome's drug for Alzheimer's-related agitation

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

23hon MSN

FDA names new director for vaccines, biologics unit

The Food and Drug Administration (FDA) has named Katherine Szarama to be the acting director of the unit in charge of regulating vaccines and other biological products for human use. An official for the Department of Health and Human Services (HHS) confirmed to The Hill that Szarama will take over the role from Vinay

STAT

Katherine Szarama named acting director of FDA’s vaccines and biologics center

Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.

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Appeals court blocks FDA rule that allows women to obtain abortion drugs by mail

A federal appeals court temporarily reinstated a nationwide requirement that abortion pills be obtained in person, undermining access to the method of abortion that has only grown more widespread since the US Supreme Court overturned Roe v.

1don MSN

FDA said to have named Katherine Szarama as acting CBER chief

The U.S. Food and Drug Administration has appointed Katherine Szarama as the acting director of its Center for Biologics Evaluation and Research, which regulates vaccines and biologic drugs, Politico reported.

New FDA analysis says US infant formula supply is safe after testing for potential contaminants

Federal health officials said a new analysis of U.S. infant formula found reassuringly low levels of heavy metals, pesticides and other potential contaminants. The U.S.

CURE

FDA Approval of Veppanu Offers New Hope for ESR1-Mutant Breast Cancer Care

FDA approval covers ER-positive/HER2-negative metastatic disease with ESR1 mutations after ≥1 endocrine line, with Guardant360 CDx enabling plasma-based selection of eligible patients. Vepdegestrant is a heterobifunctional protein degrader designed to reduce ER signaling by inducing estrogen receptor degradation,