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FDA delays full approval of Novavax Covid-19 vaccine

FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance

The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the situation told CNN.

The Wall Street Journal on MSN · 11h

FDA Misses Deadline for Covid-19 Vaccine Decision

Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration’s vaccine chief was pushed out.The agency was set to give full approval to Novavax’s shot,

Stocktwits on MSN · 10h

Novavax Vaccine Approval From FDA In Limbo, Says Report – But Retail Is Hopeful

Shares of Novavax were in the spotlight on Wednesday following reports that the company’s Covid-19 vaccine is unlikely to be approved soon. The Wall Street Journal reported on Wednesday that the U.S.

Supreme Court Rules for FDA in Flavored Vape Dispute

The Associated Press on MSN · 8h

Supreme Court sides with the FDA in its dispute over sweet-flavored vaping products

WASHINGTON (AP) — The Supreme Court on Wednesday ruled for the Food and Drug Administration in its crackdown on sweet-flavored vaping products following a surge in teen electronic cigarette use.

USA TODAY on MSN · 9h

Supreme Court throws out ruling against FDA for rejecting flavored vaping products

The FDA has rejected more than 1 million vaping products with flavors like “Jimmy the Juice Man Peachy Strawberry.”

Roll Call on MSN · 17h

Supreme Court backs FDA in flavored e-cigarette denials

The Supreme Court on Wednesday upheld FDA actions to keep certain flavored e-cigarettes off the market, unanimously backing some of the agency’s approval process but sending an issue back to a lower court for further consideration.

6hon MSN

Judge foils FDA plan to regulate lab-developed tests

The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...

1don MSN

FDA tobacco official is removed from post in latest blow to health agency’s leadership

The Food and Drug Administration’s chief tobacco regulator has been forced out. Brian King's departure Tuesday comes just ...

FDA Approves Qfitlia to Cut Bleeding Episodes in Patients With Hemophilia

The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the ...

Targeted Oncology1d

FDA Clears IND Application for CER-1236 in Advanced Solid Tumors

A second phase 1 trial plans to evaluate CER-1236, a novel chimeric antigen receptor therapy, for solid tumors.

FDA Approves Sanofi's Hemophilia Drug

The U.S. Food and Drug Administration on Friday approved Sanofi SA’s (NASDAQ:SNY) Qfitlia (fitusiran), the first antithrombin ...

Fierce Biotech8d

FDA clears first automated endoscope cleaning system with Nanosonics' CORIS

In an agency first, the FDA has cleared a system designed to clean out the complex inner channels of flexible endoscopes—a ...

Targeted Oncology18h

FDA Oncology Actions: March 2025 Approvals and Designations

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

16h

Withings $150 blood pressure monitor is FDA approved and out now

Withings . Withings has announced its BPM Vision blood pressure monitor will be available in the U.S. from April 2, having cleared the Food and Drug Administration (FDA)’s strin ...

Medical Device Network on MSN1d

FDA clears Bolt Medical’s IVL system, backing Boston Scientific’s $664m buyout

The intravascular lithotripsy market has undergone high growth trailblazed by J&J subsidiary Shockwave Medical.

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