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What is Hemgenix, world’s most expensive drug approved by FDA? How does it work?
Explainers

What is Hemgenix, world’s most expensive drug approved by FDA? How does it work?

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

Centre to create 'National Drugs Database' to monitor quality of medicines in India
India

Centre to create 'National Drugs Database' to monitor quality of medicines in India

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

FDA approves Amylyx's ALS drug despite questionable effectiveness data
World

FDA approves Amylyx's ALS drug despite questionable effectiveness data

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

Ganesh Chaturthi 2022: FDA issues guidelines for makers, sellers and buyers of sweets in Mumbai
India

Ganesh Chaturthi 2022: FDA issues guidelines for makers, sellers and buyers of sweets in Mumbai

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

Indian pharma companies tie up with US FDA: Report
Business

Indian pharma companies tie up with US FDA: Report

As part of the collaboration, the two organisations will be undertaking a two-day workshop next month to sensitize drug manufacturers within the country

FDA authorizes first COVID-19 shots for infants, preschoolers; vaccinations to begin next week
World

FDA authorizes first COVID-19 shots for infants, preschoolers; vaccinations to begin next week

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

US FDA advisers endorse first COVID-19 shots for children under the age of five
World

US FDA advisers endorse first COVID-19 shots for children under the age of five

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

US drug regulator clears COVID booster shot for healthy kids aged 5-11
World

US drug regulator clears COVID booster shot for healthy kids aged 5-11

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

FDA restricts Johnson & Johnson’s COVID-19 vaccine due to blood clot risk
Health

FDA restricts Johnson & Johnson’s COVID-19 vaccine due to blood clot risk

In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J's because of its safety issues.

US authorises new antibody drug bebtelovimab to fight Omicron
Health

US authorises new antibody drug bebtelovimab to fight Omicron

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

US expands Pfizer boosters for more teens as omicron surges
World

US expands Pfizer boosters for more teens as omicron surges

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
World

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
World

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

COVID-19 Fact Check: The Pfizer COVID vaccine is safe for children aged 5-11 years says FDA
World

COVID-19 Fact Check: The Pfizer COVID vaccine is safe for children aged 5-11 years says FDA

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.

US gives final clearance to Pfizer's COVID-19 vaccine shot for children between 5 to 11 years
World

US gives final clearance to Pfizer's COVID-19 vaccine shot for children between 5 to 11 years

The decision marks the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine

FDA panel endorses Pfizer’s low-dose COVID-19 vaccine for children aged 5 to 11 years
World

FDA panel endorses Pfizer’s low-dose COVID-19 vaccine for children aged 5 to 11 years

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

AstraZeneca seeks FDA's emergency use approval for its COVID-19 antibody treatment drug
science

AstraZeneca seeks FDA's emergency use approval for its COVID-19 antibody treatment drug

Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77 percent.

COVID deaths in US climb to more than 1,900 a day for the first time since March
World

COVID deaths in US climb to more than 1,900 a day for the first time since March

Health experts say the vast majority of the hospitalised and dead have been unvaccinated

FDA may soon grant EUA to Pfizer and Moderna COVID-19 vaccines for children aged 5-11 years
World

FDA may soon grant EUA to Pfizer and Moderna COVID-19 vaccines for children aged 5-11 years

The FDA said children that are part of the clinical trials "should be monitored for at least two months for side effects."

Unvaccinated people are 11 times more likely to die from COVID, finds CDC study
science

Unvaccinated people are 11 times more likely to die from COVID, finds CDC study

They are also 4.5 times more likely than the fully vaccinated to get infected and over 10 times more likely to be hospitalized.