BioSpace1h
FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent ...
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 ...
STAT6h
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 ...
STAT6h
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 ...
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 ...
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 ...
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 ...
Why the COVID Deniers Won
By disparaging public-health methods and discrediting vaccines, the COVID‑19 minimizers cost hundreds of thousands of people ...