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FDA, expanded access and pancreatic cancer

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Overview
 · 16h
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.

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 · 13h · on MSN
FDA authorizes early access for experimental pancreatic cancer pill
 · 15h · on MSN
US FDA authorizes early access to Revolution's pancreatic cancer pill
 · 14h
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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 · 15h
FDA expands access to drug helping pancreatic cancer patients
 · 19h
Revolution Medicines wins FDA nod to provide early access to cancer therapy

FDA, agitation and Alzheimer's

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 · 14h
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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 · 1d
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
 · 1d
US FDA approves Axsome's drug for Alzheimer's-related agitation

FDA, drug

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 · 1d · on MSN
FDA moves to exclude weight loss drugs from compounding chemicals list
The U.S. Food and Drug Administration moved on Thursday to exclude semaglutide, tirzepatide and liraglutide -- which are in several popular GLP-1 weight loss drugs -- from its 503B bulks list.

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 · 1d
FDA wants to limit compounded versions of weight loss drugs
 · 1d · on MSN
FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies
19hon 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
16h

US FDA taps Szarama as acting head of vaccine unit, Politico reports

Food and Drug Administration has named Katherine Szarama as the acting director of its vaccines and biologics ‌unit, Politico reported on Thursday, after Vinay Prasad's turbulent tenure came ‌to an end this week.
3d

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.
Infectious Disease Advisor
21h

FDA Alert: Infectious Diseases Drug News Roundup 2026

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
STAT
1d

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.
Stocktwits on MSN
16h

ARVN stock jumps 10% after FDA approves breast cancer drug a month ahead of schedule

The decision also marks the FDA’s first approval of a PROTAC therapy, a type of targeted protein-degrading drug. ・The approval is based on a Phase 3 trial, in which Veppanu reduced the risk of disease progression or death by 43% compared with Fulvestrant.
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