Usfda

FDA nod for Pfizer COVID-19 boosters for seniors, high-risk but hurdles remain

The US has already authorised third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems such as cancer patients and transplant recipients

Coronavirus Updates: Boxer L Sarita Devi, husband Thoiba Singh test COVID-19 positive

Coronavirus Updates: Devi and Thoiba are asymptomatic and are headed to a coronavirus care facility in Imphal

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

Glenmark Pharmaceuticals receives approval from USFDA to market generic drug for muscle pain in American market

Glenmark Pharmaceuticals on Wednesday said its subsidiary has received approval from the US health regulator to market Chlorzoxazone tablets, used to treat muscle pain, in the American market

Fitbit may soon make emergency ventilators to tackle COVID-19 crisis, says CEO James Park

Fitbit Inc, which is known for making activity trackers, smartwatches and wireless-enabled wearable technology, will be shifting supply chain resources to make emergency ventilators.

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

India's Jubilant Life inks licensing agreement with Gilead to manufacture Remdesivir, a potential drug to treat COVID-19

Jubilant Life Sciences Ltd on Tuesday said it has entered into a non-exclusive licensing agreement with Gilead Sciences, Inc that will grant it the right to register, manufacture and sell the latter's investigational drug, remdesivir

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

Granules India gets approval from USFDA for selling Trospium Chloride extended-release capsules

Granules India has said that it has received a nod from the US Food and Drug Administration (USFDA) for marketing Trospium Chloride extended-release capsules.

Strides Pharma gets USFDA approval to sell Flucytosine capsules to treat rare fungal infection

India-based Strides Pharma has received approval from the United States Food and Drug Administration (USFDA) to market Flucytosine capsules