FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients
Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...
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FDA approves first drug for rare lipid storage disease
An approval for the first drug for a rare lipid storage disease, some FDA workers rehired, and other biotech news of the day ...
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A viral vaccine study & rehired FDA employees
The Trump administration has started quietly re-hiring some of the FDA employees that it fired last week in a process that insiders called abrupt and haphazard, STAT’s Lizzy Lawrence reports. The ...
Pfizer names former FDA director as chief medical officer
Pfizer on Monday named the former head of the U.S. health regulator's drug evaluation unit, Patrizia Cavazzoni, as its chief ...
Invivyd shares drop as FDA declines company's COVID-19 treatment EUA expansion
Monday said that its request to expand the existing emergency use authorization of PEMGARDA (pemivibart) to include treatment of mild-to-moderate COVID-19 for immunocompromised persons who have no ...
Invivyd says FDA declines request to expand existing EUA of PEMGARDA
Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA ...
Invivyd Shares Down as Regulators Decline Expanded Use for Covid-19 Treatment
The commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more ...
Moderna norovirus vaccine trial on hold by US FDA over neurological side effect
Moderna said on Friday that the U.S. FDA paused a late-stage trial of its experimental norovirus vaccine after a case of a ...
Free COVID-19 tests are still available from the federal government
After it was reported the Trump administration would be ending the free COVID test program, the Department of Health ...
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Thomas Massie calls on FDA to 'immediately' reverse course on COVID vaccines
Ky., on Wednesday called on the Food and Drug Administration to reverse its approval of COVID-19 vaccines the agency has ...
Co-Diagnostics withdraws 510k application to FDA for Co-Dx PCR COVID-19 Test
Co-Diagnostics (CODX) announced that, following a collaborative and informative dialogue with the Food and Drug Administration, the company has ...
Co-Diagnostics Withdraws FDA Application for Covid Test
The decision to withdraw is based on discussions Co-Diagnostics had with the FDA about the ability to detect a potential deterioration of one component of the test, related to shelf-life stability, it ...