Pfizer FDA Regulatory Challenges

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FDA Will Approve COVID-19 Vaccine

FDA tightens requirements for COVID vaccine, adding trials for healthy adults

The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.

Devdiscourse · 7d

FDA Grants Conditional Approval to Novavax's COVID-19 Vaccine

· 6d

FDA Approves New Covid Vaccine

· 1d

Uncertainty loomed as FDA advisors met to discuss this year’s COVID shot

Expert advisors for the Food and Drug Administration met Thursday to discuss which virus strain this year's updated COVID-19 vaccines should target.

Arizona PBS · 1d

FDA ends routine COVID shots for healthy young Americans

STAT · 1d

FDA gives Covid vaccine manufacturers instructions for next fall’s shot

Pfizer: Better To Face The Harsh Reality Than Continue Waiting

Pfizer faces several headwinds, including patent cliffs, regulatory risks, and a setback in obesity drug development. Click to find out why PFE stock is a Hold.

BioSpace7d

After FDA Cuts, Planning for Upcoming ODAC Meeting Has Been ‘Absolute Chaos’

As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.

Makary’s FDA funding ask

FDA Commissioner Marty Makary was met with a skeptical set of Senate appropriators Thursday when he testified on his agency’s ask for funding.

KSL5d

Novavax shares jump after long-awaited FDA approval of COVID-19 vaccine

Novavax shares surged more than 17% before the bell on Monday, following the long-delayed approval of its COVID-19 vaccine, albeit with new conditions.