Hemgenix is a one-off infusion which treats haemophilia B, a rare genetic blood clotting disorder that affects around one in 40,000 people. In contrast to current treatments from Biogen, Pfizer and others which require regular infusions, Hemgenix is seen as a long-term solution
The committee will give recommendations and prepare a comprehensive database of drug formulations manufactured and marketed in the country, providing detailed information on a drug, its dosage form, strength, and details of the manufacturer, marketer, or importer of the drug
The FDA's review has become a flashpoint in broader debates about the regulatory agency, including how flexible it should be when reviewing drugs for deadly diseases and how much weight it should give to appeals from patients and other outside voices
Those found in violation of the food safety norms will be fined between Rs 25,000 and Rs 50,000. Additionally, a formal case may be filed against the offenders
As part of the collaboration, the two organisations will be undertaking a two-day workshop next month to sensitize drug manufacturers within the country
The Food and Drug Administration's action follows its advisory panel's unanimous recommendation for the shots from Moderna and Pfizer. That means US kids under 5, roughly 18 million youngsters, are eligible for the shots
More than 30,000 US children younger than five have been hospitalised with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to US health officials
Pfizer’s shot is the only COVID-19 vaccine available for children of any age in the US. Those ages 5 to 11 receive one-third of the dose given to everyone 12 and older
In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J's because of its safety issues.
The Food and Drug Administration said it cleared the Eli Lilly drug for adults and adolescent patients with mild-to-moderate cases of COVID-19 that also works against the emerging BA.2 mutation of Omicron
America is expanding COVID-19 boosters with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12
Market immunity? How public safety warnings have little impact on drug sales volumes or pharma company share prices
Under the system used by drug regulators in the US, Europe and elsewhere, drug companies need only show from clinical trials that new drugs have short-term safety and efficacy in order to gain approval
US lifts pandemic travel ban at airports and land borders from today; only vaccinated travellers allowed
According to CDC, the US will accept travellers who have been fully vaccinated with any of the vaccines approved for emergency use by the World Health Organisation, not just those in use in the US
The FDA assessed the safety of the kid-size doses in 3,100 vaccinated youngsters and has said that kids between 5 to 11 years will get just a third of the dose given to teens and adults.
The decision marks the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine
A Food and Drug Administration advisory panel voted unanimously, with one abstention, that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks
Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77 percent.
Health experts say the vast majority of the hospitalised and dead have been unvaccinated
The FDA said children that are part of the clinical trials "should be monitored for at least two months for side effects."
They are also 4.5 times more likely than the fully vaccinated to get infected and over 10 times more likely to be hospitalized.