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As the demand increases for ventilators to treat Americans with severe symptoms of COVID-19, another shortage is being exacerbated – a shortage of the drugs needed to treat patients on ventilators.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.
To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
The stimulus bill passed by the U.S. Senate March 26 on a vote of 96-0 does more than throw $2.2 trillion into the war against COVID-19. “This is not … a stimulus package. It is emergency relief,” Senate Majority Leader Mitch McConnell (R-Ky.) said on the Senate floor before the vote.
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
As if the FDA doesn’t have enough on its hands with COVID-19, Monday is deeming day. That’s the day nearly 100 drugs approved via new drug applications (NDAs) are to be deemed biologics, courtesy of the 2010 Biologic Price Competition and Innovation Act (BPCIA).
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.”
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic...
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention....
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply...
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data...
Randomized trials of the broad-spectrum antiviral favipiravir, marketed as an anti-influenza treatment by Fujifilm Holdings Corp., have shown "obvious efficacy"...
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