Us Food-and-drug-administration

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Us Food-and-drug-administration - Total results - 36
Moderna says its vaccine 94% effective against COVID-19, asks European and US regulators for emergency use
World

Moderna says its vaccine 94% effective against COVID-19, asks European and US regulators for emergency use

The US pharma company said it was on track to have about 20 million doses of its vaccine ready to ship in America by 2020-end

US to distribute 6.4 million doses of Pfizer-BioNTech COVID-19 vaccine in first tranche by year-end
World

US to distribute 6.4 million doses of Pfizer-BioNTech COVID-19 vaccine in first tranche by year-end

The federal government will issue recommendations for who should be prioritised — likely the elderly, high-risk, and frontline workers — but local authorities will make the final call

'Nobody likes me': Donald Trump complains approval rating is lower than Anthony Fauci's
World

'Nobody likes me': Donald Trump complains approval rating is lower than Anthony Fauci's

When Donald Trump restarted his coronavirus briefings last week after shutting them down in April, he largely hewed to a script, urging Americans to wear masks and practice social distancing

Drugs body CDSCO suspends import licences of 19 firms for non-USFDA COVID-19 testing kits
India

Drugs body CDSCO suspends import licences of 19 firms for non-USFDA COVID-19 testing kits

The decision was taken after the drug controller found the companies' response to a 17 July show-cause notice asking them to explain why their licences should not be suspended unsatisfactory

From dry fruits to caffeine, five foods that should be consumed in moderation during the summers
Health

From dry fruits to caffeine, five foods that should be consumed in moderation during the summers

Illnesses like the cold and flu might happen with every season change, but what makes summers particularly difficult for most people is not only the humidity and dehydration but also the heat waves.

Cipla submits application with USFDA for generic version of asthma drug
Business

Cipla submits application with USFDA for generic version of asthma drug

Drug major Cipla on Monday said it has submitted an application with the US health regulator for a generic version of GSK's Advair Diskus, which is used in the treatment of asthma and other respiratory disorders

Cipla inks licensing pact with Gilead Sciences for potential COVID-19 treatment drug remdesivir
Business

Cipla inks licensing pact with Gilead Sciences for potential COVID-19 treatment drug remdesivir

Homegrown pharma major Cipla Ltd on Wednesday said it has signed a non-exclusive licensing agreement with Gilead Sciences Inc for manufacturing and distribution of investigational drug remdesivir, a potential therapy for COVID-19

Hetero inks licensing agreement with Gilead for manufacturing, distribution of remdesivir
Business

Hetero inks licensing agreement with Gilead for manufacturing, distribution of remdesivir

Domestic pharma major Hetero on Wednesday said it has entered into a licensing agreement with Gilead Sciences Inc for manufacturing and distribution of remdesivir, a potential therapy for COVID-19

Gilead ties up with 5 generic drugmakers in India, Pakistan for COVID-19 drug supply; licensees to set price for product
Business

Gilead ties up with 5 generic drugmakers in India, Pakistan for COVID-19 drug supply; licensees to set price for product

Gilead’s antiviral drug remdesivir earlier this month received the US Food and Drug Administration’s emergency use authorization to treat COVID-19 patients.

Lupin gets inspection closure report from USFDA for Pithampur manufacturing plant in Madhya Pradesh
Business

Lupin gets inspection closure report from USFDA for Pithampur manufacturing plant in Madhya Pradesh

Drug maker Lupin on Thursday said the US health regulator has closed the inspection of its manufacturing facility in Pithampur, Madhya Pradesh

Lupin's Mandideep Unit II facility in Madhya Pradesh receives EIR from USFDA
Business

Lupin's Mandideep Unit II facility in Madhya Pradesh receives EIR from USFDA

Pharma major Lupin on Wednesday said it has received an establishment inspection report (EIR) from the US health regulator for its Mandideep Unit II facility in Madhya Pradesh

Lupin gets EIR from USFDA for Nagpur plant; MD says committed to enhance compliance, quality standards at all sites
Business

Lupin gets EIR from USFDA for Nagpur plant; MD says committed to enhance compliance, quality standards at all sites

Drug maker Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant in Nagpur

Pharma major Lupin’s Aurangabad facility gets Establishment Inspection Report from USFDA
India

Pharma major Lupin’s Aurangabad facility gets Establishment Inspection Report from USFDA

Pharma major Lupin has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Aurangabad facility.

US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold
Business

US Food and Drug Administration flags Sun Pharma's Halol plant, warns product approvals may be put on hold

Sun Pharmaceutical Industries seems to have suffered a setback as the US Food and Drug Administration (FDA) has placed its Halol plant under ‘official action indicated’.

'Aaj Se Thoda Kam': Harsh Vardhan urges Indians to eliminate foods high in fat, sugar and salt ahead of festive season
Health

'Aaj Se Thoda Kam': Harsh Vardhan urges Indians to eliminate foods high in fat, sugar and salt ahead of festive season

'Promise yourself that you shall reduce the intake of foods high in fat, sugar, and salt', said health minister Harsh Vardhan ahead of Dussehra.

MDH Sambar Masala recalled in US after Food and Drug Administration finds Salmonella contamination
India

MDH Sambar Masala recalled in US after Food and Drug Administration finds Salmonella contamination

The contaminated lot of MDH’s sambhar powder was distributed in some northern Californian stores, the drug regulator said in a statement late on Wednesday.

Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action
Business

Lupin shares fall 2.5% after USFDA says Goa facility may be subject to regulatory action

The scrip declined 2.49 percent to close at Rs 743.95 on the BSE. During the day, it dropped 5.43 percent to Rs 721.50

Zydus Cadila gets USFDA nod to market blood pressure lowering drug in the US
Business

Zydus Cadila gets USFDA nod to market blood pressure lowering drug in the US

Drug firm Zydus Cadila on Tuesday said it has received final approval from the US health regulator to market Atenolol and Chlorthalidone tablets USP, used to treat high blood pressure, in the US

Johnson and Johnson: Drug regulator likely to seize talcum powder samples for testing in countrywide raids today
India

Johnson and Johnson: Drug regulator likely to seize talcum powder samples for testing in countrywide raids today

India’s drug regulator is likely to investigate Johnson and Johnson baby powder following recent reports that said the company knew for decades about the presence of cancer-causing asbestos in the product.

Johnson & Johnson knew about cancer-causing asbestos lurking in its baby powder since decades, says report; company shares nosedive
World

Johnson & Johnson knew about cancer-causing asbestos lurking in its baby powder since decades, says report; company shares nosedive

Shares of Johnson & Johnson fell 10 percent on Friday and were on track to post their biggest percentage drop in more than 16 years, after Reuters reported that the pharma major knew for decades that cancer-causing asbestos was present in its Baby Powder.