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FDA, Supreme Court

CNN on MSN · 1h

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.

Reuters on MSN · 47m

US Supreme Court wrestles with FDA denial of flavored vape products

The U.S. Supreme Court examined on Monday the U.S. Food and Drug Administration's refusal to let two e-cigarette companies sell flavored vape products that regulators consider a health risk to youths,

New York Post · 1h

Supreme Court appears sympathetic to FDA as agency seeks to block some flavored vapes appealing to minors

Most Supreme Court justices sounded skeptical of claims Monday that the Food and Drug Administration wrongly moved the goalposts on its standards in the middle of its decision-making process when

Cytokinetics, FDA and New Drug Application

Business Insider · 1h

Cytokinetics announces FDA acceptance of NDA for aficamten

Cytokinetics (CYTK) announced that the U.S. Food & Drug Administration has accepted the company’s New Drug Application for aficamten, a

Seeking Alpha on MSN · 3h

Cytokinetics' application for aficamten accepted by FDA

Cytokinetics (NASDAQ:CYTK) said the FDA has accepted its New Drug Application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy, or HCM. The agency assigned a target action date of Sept.

The Bakersfield Californian · 6h

Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment ...

The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

18m

Ex-FDA Commissioner Says RFK Jr. 'Will Cost Lives' As Head Of Health Department

Scott Gottlieb, who served early on in Trump's first term, is now warning senators about the impact Kennedy could have on ...

Pharmalittle: We’re reading about a former Trump FDA chief criticizing RFK Jr., a radiopharmaceuticals talent shortage, and more

Former FDA commissioner Scott Gottlieb is raising concerns with Senate Republicans about the president-elect’s selection of ...

FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona ...

1hon MSN

Regulatory chaos: How conflicting interpretations of breast implants are undermining the FDA's reputation

A new Reichman University study examines how conflicting interpretations regarding breast implants risk the erosion of the ...

4h

FDA grants breakthrough device designation to deepull’s BSI test

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9hOpinion

Editorial: A small but important win for FDA under fire

Given how the U.S. Supreme Court’s conservative majority is better known for limiting the authority of federal regulatory ...

1d

Pie Recall Update As FDA Sets Most Serious Risk Level

Products sold in the Northwest have been given the highest risk status, but so far no illnesses have been reported.

FDA’s Accelerated Approval Pathway Drives Momentum for Intractable, Fatal Diseases

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

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