FDA

Moderna’s COVID-19 vaccine applies for FDA authorization – What that means

Moderna’s COVID-19 vaccine applies for FDA authorization – What that means

Pharmaceutical company Moderna will request Emergency Use Authorization from the US FDA for its COVID-19 vaccine today, the next big hurdle in getting doses of the drug out of trials and into public use. Moderna announced primary results from its Phase 3 study of mRNA-1273 - which it developed as a potential vaccine candidate for the coronavirus - earlier in the month.

Continue Reading

Fresh basil recalled in several states over risk of parasitic infection

Fresh basil recalled in several states over risk of parasitic infection

Around 15,000 units of fresh basil have been recalled in several states over the risk of Cyclospora, a parasite that can cause illness in people who contract it. The recall is described as voluntary and made 'out of an abundance of caution' after the Florida Department of Agriculture tested one package and identified the possible contamination.

Continue Reading

FDA says romaine hearts recalled in 15 states over E. coli risk

FDA says romaine hearts recalled in 15 states over E. coli risk

Romaine hearts, the tall and crunchy center mass of romaine lettuce that is often sold in packages, is the subject of a new recall in 15 states. The recall is for a familiar reason: the risk of E. coli contamination, which can lead to severe illness in some people, though this recall is for a non-outbreak strain. As with other recent romaine recalls, there's some good news to go along with the advisory.

Continue Reading

Pfizer COVID-19 vaccine EUA submission – Timeline to doses

Pfizer COVID-19 vaccine EUA submission – Timeline to doses

Pfizer's COVID-19 vaccine has been submitted to the US FDA for emergency use authorization, paving the way for use of the drug potentially as soon as mid-December 2020. The vaccine candidate, co-developed with German firm BioNTech, has indicated a 95-percent success rate in Phase 3 trials, with no signs of serious safety concerns or side-effects.

Continue Reading

First COVID-19 at-home test FDA authorized for rapid results

First COVID-19 at-home test FDA authorized for rapid results

The FDA has approved the first at-home COVID-19 test offering rapid results, one that is only available via prescription. The test is designed for use with individuals 14 years or older who potentially have been exposed to the virus, eliminating the need to visit a hospital or doctor's office in person. The approval was given for the test via an Emergency Use Authorization.

Continue Reading

FDA says salad mix recalled over bacteria, but there’s good news

FDA says salad mix recalled over bacteria, but there’s good news

Some cases of mixed salad have been recalled by Fresh Express because of potential contamination with E. coli bacteria. No illnesses were reported in association with the recalled products, which were distributed mostly in the western and southwestern United States. Most consumers likely have nothing to worry about, however.

Continue Reading

Moderna COVID-19 vaccine said 94.5% effective – and there’s more good news

Moderna COVID-19 vaccine said 94.5% effective – and there’s more good news

Moderna has announced new results for its COVID-19 vaccine candidate, claiming a 94.5-percent efficacy rate for the coronavirus drug. The news comes from the company's Phase 3 study of mRNA-1273, which enrolled more than 30,000 participants, of which 95 had confirmed cases of COVID-19.

Continue Reading

FDA says more dog food recalled in several states over salmonella risk

FDA says more dog food recalled in several states over salmonella risk

The US Food and Drug Administration has highlighted yet another dog food recall, this one over the risk of salmonella contamination. As with humans who handle the food, dogs that eat food contaminated with salmonella at risk of becoming ill, plus they can then spread the infection to humans by, for example, licking their hands or face.

Continue Reading

Pfizer COVID-19 vaccine shows 90% efficacy – What we do and don’t know

Pfizer COVID-19 vaccine shows 90% efficacy – What we do and don’t know

Pfizer's COVID-19 vaccine has passed a significant milestone, with the company announcing the early results from its coronavirus trial have shown the drug to be more than 90-percent effective. It's a strong note of confidence for the mRNA-based vaccine, though a relatively small sample size - among other factors - does mean there's still some way to go before celebrating.

Continue Reading

Apple Watch NightWare nightmare disorder app gets FDA authorization

Apple Watch NightWare nightmare disorder app gets FDA authorization

Many smartwatches and fitness bands these days offer some form of sleep monitoring or another. The most they can do, however, is tell you how well or poorly you slept. There's really not much help it can offer to those suffering from regular nightmares, especially those induced by PTSD. That may soon be changing, even if only a little bit, with the FDA's approval to market the NightWare system for the Apple Watch precisely to help reduce adult sleep disturbance caused by these nightmares.

Continue Reading

FDA says more romaine lettuce recalled over risk of E. coli

FDA says more romaine lettuce recalled over risk of E. coli

A new romaine lettuce recall has been issued, this one over potential contamination with E. coli. The recall covers romaine lettuce sold as single head products and was voluntarily made 'out of an abundance of caution,' according to Tanimura & Antle, Inc., the company behind the recall. The lettuce was sold in 20 states around the US.

Continue Reading

Bombshell CDC report reveals 1-in-3 early COVID-19 tests failed

Bombshell CDC report reveals 1-in-3 early COVID-19 tests failed

Not only delayed, the first COVID-19 tests from the US CDC had a huge failure rate a new report claims, with leaked findings from within the agency suggesting that as many as 1-in-3 tests could fail. The revelation comes as new coronavirus cases in the US exceeded 106,000 a day across America, with total deaths now numbering more than 233,000.

Continue Reading

1 2 3 4 Next