The company has the FDA is doing a pre-approval inspection for drug application it made in the US
Experts say COVID vaccines in children may not provide any additional benefit as most have already developed immunity as they have been exposed to the infection earlier.
The oncologists feel that a huge political will is needed to establish nicotine level on tobacco products in India.
The Food and Drug Administration will draft a rule that limits nicotine, according to a notice of a proposed rule posted on the US Office of Information and Regulatory Affairs.
The 21-member committee advising the Food and Drug Administration voted unanimously in favor of clearance for Pfizer’s three-dose vaccine for youngsters ages six months through 4 years.
The FDA said it expected Abbott to restart production in about two weeks. The agreement stems from a US Department of Justice complaint and consent decree with the company and three of its executives
Electronics engineer Neha Rastogi and Rahul Rastogi said Agatsa is working with different agencies for US FDA clearances and CE validations because of the high demand for small ECG machines in the international markets.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The agency said there are safety concerns regarding self-collection of throat swabs, "as they are more complicated than nasal swabs, and if used incorrectly, can cause harm to the patient."
A panel of US health advisers narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorisation of the first drug that Americans could take at home to treat the virus.
According to a press release issued by the city-based drug maker, the FDA approved Lenalidomide capsules in 2.5 mg and 20 mg strengths and gave tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is used to treat various types of cancers.
Unable to settle the best timing, the FDA’s advisory panel voted unanimously that the booster should be offered at least two months after people got their earlier shot.
This has made the two-shot Pfizer vaccine the first to receive full approval from the federal government.
The announcement by the Food and Drug Administration applies to millions of Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.
The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk" for those getting the shot.
The FDA approval isn't limited to those early patients. Anyone with Alzheimer's at least theoretically could get prescribed the drug. But advocacy groups like the Alzheimer's Association and many doctors say the focus should be patients with an early diagnosis.
For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.
Bharat Biotech’s American partner Ocugen has dropped the plan to seek an emergency approval for the coronavirus jab based on a recommendation from the US FDA.
While the Centers for Disease Control and Prevention recommends health care workers get a flu shot, and some hospital systems require it, few companies have required COVID-19 shots, despite federal government guidance that says employers can mandate vaccines for on-site workers.
The FDA approved Aduhelm for the treatment of Alzheimer's disease. The decision did not define the patient population for whom the treatment is appropriate.
In black fungus treatment, liposomal amphotericin B is the drug of choice for most doctors as it does not have side-effects associated with the conventional alternative but is in short supply.
The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the now-idle Emergent Biosciences factory.
Homeland Security investigators are working with Pfizer, Moderna and dozens of other drug companies racing to complete and distribute the vaccine and treatments for the virus. The goal: to prepare for the scams that are coming, especially after the mess of criminal activity this year with phony personal protective equipment, false cures and extortion schemes.
The US Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy..
The drug, aducanumab, would not stop or reverse dementia, but some evidence suggests it can slow the progression of memory and thinking problems in people with mild or early symptoms of cognitive decline.