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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.

· 15h · on MSN

FDA authorizes early access for experimental pancreatic cancer pill

· 16h · 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, Drug Administration

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· 18h

FDA moves to limit compounding of GLP-1s

The FDA proposed Thursday not adding three active ingredients in weight-loss drugs to its so-called bulks list, which allows large compounding facilities to make knockoff versions of branded products ...

· 1d · on MSN

FDA moves to exclude weight loss drugs from compounding chemicals list

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FDA wants to limit compounded versions of weight loss drugs

FDA, Breast Cancer and Arvinas

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· 11h

US FDA Approves Pfizer, Arvinas' Breast Cancer Drug

The U.S. Food ⁠and ⁠Drug Administration on Friday approved ⁠Pfizer and Arvinas' breast cancer drug for patients with an advanced form of the disease whose tumors carry a specific genetic mutation.

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Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

· 1d · on MSN

FDA panel votes against AstraZeneca’s breast cancer drug

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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.

Fierce Pharma

FDA expectations create potential friction in new Form 483 response guidance

Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the receipt of a Form 483.

Smithsonian Magazine

The FDA Approves the First-Ever Gene Therapy for Deafness, Which Aims to Restore Hearing in Kids With a Rare Inherited Condition

The agency's decision is based on results from a clinical trial in which the treatment improved hearing in 80 percent of the pediatric participants. However, Deaf community advocates worry about the p

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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

Infant formula largely safe from heavy metals, FDA finds

FDA sampled 312 major infant formula brands and found low or undetectable levels of pesticide residue, PFAS, heavy metals and phthalates.

17h

FDA Recalls Several Ghirardelli Powdered Beverages Over Potential Contamination

Ghirardelli issued the recall out of caution following a previous recall of potentially contaminated milk powder from a third-party supplier, California Dairies, Inc. That milk powder is one of the ingredients used in the affected beverage mixes,

30 Years Ago, the FDA Tried to Regulate Supplements—Then Mel Gibson Got Involved

A 1994 law unleashed today’s supplement boom and created a $70 billion industry. Here's why critics say it's a ticking time bomb.

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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. The extended-release tablet is the first FDA-approved medication for this condition that is not an anti-psychotic.