Page 6 - Us Fda

Indian drugmaker Fresenius Kabi sentenced to pay $50 million in US fines

The company pleaded guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration (FDA) plant inspection, the Department of Justice said

US promotes 'serial testing' for Covid-19 with streamlined approval

The US government issued simplified rules for developers of coronavirus tests to promote serial screening, a process in which the same individual is tested multiple times within a few days

Donald Trump says Moderna's vaccine approved; US FDA denies claim

Panel of external experts endorse vaccine use with a resounding 20-0 vote

US FDA nod for Pfizer's Covid-19 vaccine 'in days' after panel's support

A panel of outside advisers to the FDA on Thursday voted overwhelmingly to endorse emergency use of the vaccine, paving the way for the agency to authorize the shot

US panel endorses mass use of Pfizer Covid vaccine, shots may begin in days

A US government advisory panel has endorsed Pfizer's coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak.

Pfizer-BioNTech's Covid-19 vaccine deliveries may start before Christmas

(Reuters) - Pfizer Inc and BioNTech <22UAy.DE> could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

Five questions you should be asking about Pfizer's coronavirus vaccine

Important scientific announcements are usually made through peer-reviewed medical research papers, not company press releases

Combative US FDA panel votes against Biogen Alzheimer's treatment drug

A panel of outside advisers to the US FDA voted that a potential Alzheimer's treatment from Biogen has not been proven to slow the progression of the disease

Shilpa Medicare slips 12% on USFDA warning letter for Telangana facility

The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility

Covid-19: White House could veto FDA's vaccine rules, says Donald Trump

The FDA may issue final rules in coming days for issuing an emergency-use authorisation for a coronavirus vaccine.

Trump wants a vaccine by end of this year but the barriers are too high

But the administration has also offered timelines for a vaccine that fly in the face of almost every experience in pharmaceutical history

Here's why Bill Gates doesn't trust US FDA and CDC even amidst a pandemic

Like the rest of US, Gates, who is 64, is now in the unfamiliar position of having to put his faith in the companies working on Covid-19 treatments and vaccines, not the agency that regulates them

Not just pledge, here's what will build public confidence in Covid vaccine

The Trump administration has exerted relentless political pressure on public health officials to approve a vaccine quickly, with the president pushing for a vaccine by Election Day

Zydus Cadila gets tentative US FDA approval for generic diabetes drug

Drug firm Zydus Cadila said it has received approval from the US health regulator to market diabetes drug, Empagliflozin and Linagliptin tablets, in the US market

Strides Pharma gets US FDA nod for generic anti-inflammatory drug

Drug firm Strides Pharma Science on Thursday said it has received approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication. Strides Pharma Global Pte Ltd, Singapore, company's step-down wholly owned subsidiary, has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE. The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,the filing said. According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added. Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It i

US FDA-approved ointment found to treat, kill infections including Covid

Scientists associated with the project said the FDA-registered non-prescription over the counter (OTC) ointment has been proven to prevent, treat and kill viral infections including coronavirus

Gilead seeks US FDA approval for experimental coronavirus drug remdesivir

The antiviral drug has been at the forefront of the battle against the pandemic after the FDA granted it emergency use authorization (EUA) in May

US FDA approves GlaxoSmithKline's experimental drug for blood cancer

Multiple myeloma is the second most common form of blood cancer in the US and is generally considered treatable, but not curable

AstraZeneca's drug gets US FDA nod to treat lung disease patients

The drug Breztri Aerosphere is being approved as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), the third leading cause of death globally

US approved 4 Covid-19 vaccine candidates for clinical trials: FDA head

The US Administration launched in May Operation Warp Speed, a joint project of Health and Defense Departments, which aims to deliver 300 million doses of a vaccine for Covid-19 by January 2021