Page 10 - Us Fda
Tracing Covid-19's origin: Five ways US is pressing China to solve mystery
In the past few weeks, the United States has pressed China on tracing the origin of the virus.
 "Tracing Covid-19's origin: Five ways US is pressing China to solve mystery")
FDA authorises third antibody drug for mild-to-moderate Covid-19 cases
U.S. health officials have granted emergency authorisation to a third antibody drug to help reduce hospitalisations and deaths due to Covid-19
 "FDA authorises third antibody drug for mild-to-moderate Covid-19 cases")
Bharat Biotech's US partner Ocugen submits 'Master File' to FDA on Covaxin
Ocugen, Bharat Biotech's American partner for Covaxin, has submitted a 'Master File' to the US Food and Drug Administration prior to seeking an emergency use authorisation in that country
 "Bharat Biotech's US partner Ocugen submits 'Master File' to FDA on Covaxin")
Bharat Biotech in talks for clinical trials of Covaxin in US: Report
Bharat Biotech submitted 90% of documents to WHO for obtaining emergency use listing for Covaxin vaccine, say sources
 "Bharat Biotech in talks for clinical trials of Covaxin in US: Report")
US FDA to authorise Pfizer jabs for 12 to 15-year-old by next week
Vaccinating adolescents may also be key to boost immunity levels in the general population
 "US FDA to authorise Pfizer jabs for 12 to 15-year-old by next week")
US says it will share 60 million AstraZeneca vaccine doses with world
The inoculation is used around the world but has not yet been authorised by the US Food and Drug Administration.
 "US says it will share 60 million AstraZeneca vaccine doses with world")
Pfizer asks US FDA to clear its coronavirus vaccine for use in kids
Pfizer and BioNTech have asked the US Food and Drug Administration (FDA) to expand the Emergency Use Authorization (EUA) for its Covid-19 vaccine to include children ages 12 to 15.
US FDA nod to Teva for key specialty product to weigh on Sun Pharma
Strong US portfolio, margin gains and India business growth to support stock
 "US FDA nod to Teva for key specialty product to weigh on Sun Pharma")
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
 "Indian drugmaker Fresenius Kabi sentenced to pay $50 million in US fines")
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
 "US promotes 'serial testing' for Covid-19 with streamlined approval")
Donald Trump says Moderna's vaccine approved; US FDA denies claim
Panel of external experts endorse vaccine use with a resounding 20-0 vote
 "Donald Trump says Moderna's vaccine approved; US FDA denies claim")
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 FDA nod for Pfizer's Covid-19 vaccine 'in days' after panel's support")
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.
 "US panel endorses mass use of Pfizer Covid vaccine, shots may begin in days")
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.
 "Pfizer-BioNTech's Covid-19 vaccine deliveries may start before Christmas")
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
 "Five questions you should be asking about Pfizer's coronavirus vaccine")
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
 "Combative US FDA panel votes against Biogen Alzheimer's treatment drug")
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
 "Shilpa Medicare slips 12% on USFDA warning letter for Telangana 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.
 "Covid-19: White House could veto FDA's vaccine rules, says Donald Trump")
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
 "Trump wants a vaccine by end of this year but the barriers are too high")
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
 "Here's why Bill Gates doesn't trust US FDA and CDC even amidst a pandemic")