Us Drug Regulator

Rapid Covid home tests are more likely to give a false negative with the heavily-mutated Omicron variant compared to earlier strains, the US Food and Drug Administration (FDA) said Tuesday.

The US Food and Drug Administration (FDA) on Wednesday authorized Pfizer's Covid pill for high-risk people aged 12 and over, a major milestone in the pandemic that will allow millions to access the treatment.

Drug firm Zydus Cadila on Friday said it has received approval from the US health regulator to market generic drug Cariprazine capsules, which are used in the treatment of schizophrenia.

The country's drug regulator today allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of US drugmaker Novavax's COVID-19 vaccine.

Moderna on Wednesday announced it had begun submitting an application to the US Food and Drug Administration to authorize a booster of its Covid vaccine after trial data showed a significant increase in antibodies against variants.

A cybersecurity flaw in a software designed by BlackBerry could put at risk cars and medical equipment that use it and expose highly sensitive systems to attackers, the US drugs regulator and a federal agency said.

U.S. drug regulators are set to clear a third dose of Covid vaccines for people with weak immune systems as a new study showed the benefits of an extra shot in transplant patients.

A surge in Covid-19 cases across the U.S. brought on by the fast-spreading delta variant is increasing pressure on U.S. drug regulators to fully approve Pfizer Inc.'s vaccine, the first one to apply for full licensure in the U.S.

The fact sheet for Johnson & Johnson's Covid-19 vaccine was revised to warn of the risk of a rare immune-system disorder, adding new headwinds for a shot once expected to be a linchpin of the US immunization effort.

The government on Tuesday cleared the fourth vaccine for emergency use in the country, the US-made Moderna.

Goa has given the nod for the use of an anti-parasitic drug as preventive treatment for all adults against COVID-19. The drug, Ivermectin, has been disapproved of by the US Food and Drug Administration (FDA).

Europe's medicines regulator said Wednesday it will make a recommendation on the safety of Johnson & Johnson's coronavirus jab next week after US health authorities recommended pausing vaccinations over blood clot fears.

Top US health authorities said Friday they have not yet found a "causal" link between Johnson & Johnson's Covid shot and blood clots, as the EU drug regulator probed possible instances among those who have received the vaccine.

Johnson & Johnson's one-shot COVID-19 vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for its approval for emergency use.

Pfizer Inc will pursue its request for India to approve its COVID-19 vaccine if the government commits to buying shots, the US drugmaker told Reuters on Monday, even as global supplies tighten.

Rapid Covid home tests are more likely to give a false negative with the heavily-mutated Omicron variant compared to earlier strains, the US Food and Drug Administration (FDA) said Tuesday.

The US Food and Drug Administration (FDA) on Wednesday authorized Pfizer's Covid pill for high-risk people aged 12 and over, a major milestone in the pandemic that will allow millions to access the treatment.

Drug firm Zydus Cadila on Friday said it has received approval from the US health regulator to market generic drug Cariprazine capsules, which are used in the treatment of schizophrenia.

The country's drug regulator today allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of US drugmaker Novavax's COVID-19 vaccine.

Moderna on Wednesday announced it had begun submitting an application to the US Food and Drug Administration to authorize a booster of its Covid vaccine after trial data showed a significant increase in antibodies against variants.

A cybersecurity flaw in a software designed by BlackBerry could put at risk cars and medical equipment that use it and expose highly sensitive systems to attackers, the US drugs regulator and a federal agency said.

U.S. drug regulators are set to clear a third dose of Covid vaccines for people with weak immune systems as a new study showed the benefits of an extra shot in transplant patients.

A surge in Covid-19 cases across the U.S. brought on by the fast-spreading delta variant is increasing pressure on U.S. drug regulators to fully approve Pfizer Inc.'s vaccine, the first one to apply for full licensure in the U.S.

The fact sheet for Johnson & Johnson's Covid-19 vaccine was revised to warn of the risk of a rare immune-system disorder, adding new headwinds for a shot once expected to be a linchpin of the US immunization effort.

The government on Tuesday cleared the fourth vaccine for emergency use in the country, the US-made Moderna.

Goa has given the nod for the use of an anti-parasitic drug as preventive treatment for all adults against COVID-19. The drug, Ivermectin, has been disapproved of by the US Food and Drug Administration (FDA).

Europe's medicines regulator said Wednesday it will make a recommendation on the safety of Johnson & Johnson's coronavirus jab next week after US health authorities recommended pausing vaccinations over blood clot fears.

Top US health authorities said Friday they have not yet found a "causal" link between Johnson & Johnson's Covid shot and blood clots, as the EU drug regulator probed possible instances among those who have received the vaccine.

Johnson & Johnson's one-shot COVID-19 vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for its approval for emergency use.

Pfizer Inc will pursue its request for India to approve its COVID-19 vaccine if the government commits to buying shots, the US drugmaker told Reuters on Monday, even as global supplies tighten.