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FDA, Bizengri
FDA approves AstraZeneca's Imfinzi for limited-stage small cell lung cancer
The U.S. Food and Drug Administration has approved AstraZeneca blockbuster drug Imfinzi to treat some adults with limited-stage small cell lung cancer, the health regulator said on Wednesday.
FDA approved Bizengri for NSCLC and pancreatic cancers harboring NRG1 gene fusion
The systemic agent is the first approved by the FDA for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion.
Merus Gets FDA Approval for Bizengri Treatment
The clinical-stage oncology company on Wednesday said Bizengri is its first approved medicine based on the proprietary Biclonics technology platform. The approval is based on data from the eNRGy trial,
US FDA approves Merus' therapy to treat lung, pancreatic cancers
The U.S. Food and Drug Administration has approved Merus NV's therapy that targets a particular gene, expanding treatment options for patients with hard-to-treat type of lung and pancreatic cancers, the health regulator said on Wednesday.
FDA, Supreme Court
Supreme Court wrestles with FDA’s attempt to curb access to flavored vapes
The Supreme Court on Monday pressed the Food and Drug Administration on whether it followed the law in its effort to keep flavored e-cigarettes off shelves, weighing a lawsuit from a multibillion-dollar industry that has come under scrutiny because its products are popular with school-aged children.
Supreme Court grapples with FDA's refusal to approve flavored vapes
As e-cigarettes have flooded the market, the FDA's role in approving new tobacco products is put under a microscope.
Supreme Court didn’t seem convinced FDA was unfair in blocking flavored vapes amid rise in teen use
Supreme Court justices questioned an FDA crackdown that involved rejections on sales of more than a million nicotine products created to taste like fruit and candy.
Psychology Today
2h
FDA Under Trump and the Future of Psychedelics
With Trump back in the White House, will FDA policies on psychedelics shift? What's the impact on mental health care and ...
11h
on MSN
Supplement Recall Update: FDA Adds Two More Toxic Products to Safety Alert
A safety alert by the FDA now covers 25 products sold as tejocote but found to contain a toxic plant called yellow oleander.
11h
RFK Jr. Says He Wants To Untie Links Between Industry And FDA
It's unclear to what extent RFK Jr would want to disrupt a drug review process that has given the US a comparative advantage, ...
FiercePharma
1h
FDA signs off on Merus' first-in-class NRG1+ cancer drug Bizengri after brief delay
Merus’ week keeps getting better. Days after securing a long-awaited commercialization partner for its zenocutuzumab, the ...
5h
on MSN
Sauce Recall Update as FDA Sets Risk Level
Anyone who thinks they may have suffered a reaction due to undeclared allergens should also "notify the FDA and local health ...
STAT
10h
Compounding pharmacies rebut Novo’s FDA petition
The Alliance for Pharmacy Compounding rebutted Novo's FDA petition to bar compounding pharmacies from copying its weight loss ...
soapcentral
12h
FDA announces carrots, broccoli, and more vegetables recall due to possible E.coli contamination: Drama explained
In the latest twist, the FDA has recalled multiple brands of Organic Vegetable Medley sold at grocery stores like Walmart, ...
5h
on MSN
FDA tags Wegovy with new warning for gastrointestinal reactions
Participants in Wegovy clinical trials were more likely to report “severe gastrointestinal adverse reactions,” the FDA's ...
13h
on MSN
How the FDA allows companies to add secret ingredients to our food
The FDA allows food makers to vouch for the safety of ingredients they add to our food, calling them 'generally recognized as ...
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