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US Food and Drug Administration News

06 May 2022

US FDA limits use of Johnson & Johnson Covid-19 vaccine over blood clot risk

The Johnson and Johnson vaccine was authorised for emergency use in February last year. As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. FDA said the shot should only be given to adults who cannot receive a different vaccine.

21 Oct 2021

US approves new booster of COVID-19 vaccines, mix and match dose

FDA approved the use of third doses of Moderna and Johnson & Johnson vaccines. FDA also approved "mix and match" booster doses.

13 Aug 2021

WHO trial to study potential of 3 anti-malarial drugs against COVID-19

Artesunate will be administered to Covid-19 patients intravenously for seven days Imatinib will be given once daily for 14 days Infliximab will be injected in one single dose

12 Dec 2017

'Flushable' pregnancy test gets FDA's approval; set for 2018 launch

Made with a special paper that works long enough to take the test and but then degrades in water, the pregnancy test has no glass and requires no batteries.

21 Nov 2017

Silver lining for leukemia patients, new possibility for cure found

The development comes after the US Food and Drug Administration last year approved a cell-based gene therapy, namely the CAR T-cell treatment.

20 Nov 2017

Sensex little changed; PSU banks down

Moody`s Investors Service upgraded India`s sovereign credit rating for the first time in nearly 14 years on Friday, saying continued progress on economic and institutional reforms would boost the country`s growth potential.

14 Nov 2017

In a first, US regulators approve pill that digitally tracks patients' medication intake

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions.

30 Aug 2017

US approves first gene therapy for cancer

Gene therapy is a treatment that uses a patient`s own immune cells to fight leukemia.

29 Aug 2017

Sindoor may carry religious significance, but it is unsafe too! - Read

The FDA’s limit for lead in cosmetics is 20 micrograms per gram. Nineteen percent of the US samples and 43 percent of the India samples exceeded that limit.

28 May 2017

Personalised cancer drug approved in US

Pembrolizumab is indicated for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

08 Apr 2017

FDA clears genetic test to predict Alzheimer's, Parkinson's diseases

The US Food and Drug Administration (FDA) has allowed 23andMe, a genetic testing company, to market its "controversial" direct-to-consumer tests for assessing the risk for 10 diseases or conditions, including Alzheimers and Parkinsons disease.

Multiple sclerosis

01 Apr 2017

US FDA approves first drug 'Ocrevus' to treat aggressive multiple sclerosis

US Food and Drug Administration regulators have approved the first drug 'Ocrevus' to treat adult people with an aggressive kind of multiple sclerosis.

12 Jan 2017

Texas carries out first US execution of 2017 amid dispute

Texas prison authorities have carried out the first US execution of 2017, as controversy continued to swirl around the drugs used to conduct such lethal injections.

26 Dec 2016

Lupin receives USFDA nod for hypertension treatment drug in US

Drug major Lupin has received tentative approval from the US health regulator to sell Olmesartan medoximil tablets, used for treating high blood pressure, in the American market.

01 Oct 2016

FDA issues warning against homeopathic teething products, says it may harm infants

Consumers should stop using these products and dispose of any in their possession, FDA recommended on Friday.

25 May 2016

Zydus Cadila gets USFDA's final nod for fungal treatment drug

The Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Voriconazole tablets in strengths of 50 and 200 mg, Cadila Healhtcare said in a BSE filing.

Dr Reddy's Laboratories

06 Apr 2016

USFDA actions hurting exports, need govt intervention: Dr Reddy's

Asserting that regulatory action by the US Food and Drug Administration (USFDA) on leading Indian firms has impacted exports from the country, Dr Reddy's Laboratories Chairman Satish Reddy Wednesday asked for a dialogue between government and US health regulator.

Aurobindo Phrama

01 Apr 2016

Aurobindo Pharma gets final USFDA nod for anti-viral drug

Aurobindo Pharma has received final approval from the US health regulator to manufacture and market anti-viral Valganciclovir tablets in the American market.

30 Jan 2016

Blood pressure drug may treat Alzheimer's disease

A drug used to treat high blood pressure has been found to reduce cell damage often linked to Alzheimer's disease, reports a new study.

Dr Reddy's Laboratories

25 Nov 2015

US FDA warns of DRL drug import ban if flaws are not fixed

The US Food and Drug Administration (US FDA), which had issued a warning letter to Dr Reddy's Laboratories over quality issues, has said it might withhold approval of the company's fresh drugs and stop import if no corrective action is taken.

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