FDA Approval Process - Search News

FDA, Moderna and Flu Vaccine

FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology that’s been a target of some Trump administration health officials.

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Moderna shares fall as FDA declines to review new flu vaccine

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Moderna Stock Slips After FDA Refuses Flu Vaccine Review

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FDA Refuses to Consider Approving Use of Moderna’s New Flu Vaccine

The U.S. Food and Drug Administration refused to review Moderna ’s application to sell a new seasonal flu vaccine.

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Kennedy-era FDA changes vaccine review process, blocks Moderna application

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FDA refuses to review Moderna's flu vaccine application

Yahoo

Changing the FDA’s Vaccine Approval Process Could Threaten COVID, Flu Protection for Children

Add Yahoo as a preferred source to see more of our stories on Google. The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific ...

JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will receive assurance of agency ...

Pharmaceutical Technology on MSN

FDA’s commissioner vouchers prompt questions about award process

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear.

WLWT

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate approvals for cheaper alternatives for medications ...

WISN 12 NEWS

FDA official plans to change vaccine approval process

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: White House links Tylenol in pregnancy to autism ...

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Ballot measure would make NV testing ground for bypassing FDA approval

A Las Vegas-based biotech CEO has a vision of Nevada as a hub for medical innovation, and he is hoping voters will help him make it happen.