Us Drug Regulator
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Could Dogs Live Longer? Breakthrough Pill Receives Key Regulator Approval
FDA could allow the drug into the market, as soon as next year, once Loyalhits certain safety and manufacturing milestones.
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Elon Musk's Neuralink Gets Go Ahead For Brain Chip Implant In 2nd Patient: Report
The US health regulator has allowed billionaire Elon Musk's Neuralink to implant its brain chip in a second person after it proposed to fix a problem that occurred in its first patient, the Wall Street Journal reported on Monday.
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1st Over-The-Counter Birth Control Pill Approved In US
The US drug regulator approved the first over-the-counter birth control pill in the country, it announced Thursday, dramatically widening access to contraception for women as the United States grapples with reproductive rights.
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US Makes New Alzheimer's Drug More Widely Accessible
The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly.
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"No Contamination Found": Tamil Nadu Official As US Flags Indian Eye Drop
Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by Chennai-based Global Pharma, which has hit headlines after a US watchdog linked cases of infections, blindness and even deaths to the eye drops.
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US Health Regulator Lists 378 Hand Sanitisers Consumers Should Not Use
Amid rising COVID-19 cases in China, the US Food and Drug Administration (FDA) released a list of hand sanitisers it recommends avoiding.
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"Drug Products Adulterated": US Regulator Warns Sun Pharma's Gujarat Plant
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.
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LASIK Patients Should Be Warned of Risks Before Eye Procedure, Says US Health Regulator
LASIK - Laser-Assisted In Situ Keratomileusis - is the most commonly performed laser refractive surgery used to correct common vision problems. However, the surgery is now under the lens of the US Food and Drug Administration (FDA).
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Pharma Firm Lupin Gets US Regulator Nod For Generic Drug To Treat Cancer
Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America.
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US Experts Recommend Novavax COVID-19 Vaccine
A panel of experts convened by the US drug regulator on Tuesday recommended the Novavax Covid-19 shot, a late runner in the fight against the virus that could nonetheless play a role in overcoming vaccine hesitancy.
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US Health Regulator Lifts Hold On Covaxin's Clinical Trials
The US Food and Drug Administration which has put on hold phase 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin, in USA, has lifted pause, according to a statement issued by Ocugen Inc, Bharat Biotech's partner for jab in US, Canada
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Moderna Seeks Emergency Approval For Second Covid Booster For US Adults
Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults.
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US Is Considering Second Covid Booster For 65+
Pfizer and BioNTech announced Tuesday they had formally asked the United States drug regulator for emergency approval of a second booster shot of their Covid vaccine for people aged 65 and older.
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US Health Regulator Clears Covaxin For Clinical Trials In Adults In America
Bharat Biotech's COVID-19 vaccine Covaxin has been given clearance for clinical trials in adults by the US Food and Drug Administration (FDA).
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For Omicron, Rapid Covid Tests Not As Accurate: US Regulator
Rapid Covid home tests are more likely to give a false negative with the heavily-mutated Omicron variant compared to earlier strains, the US Food and Drug Administration (FDA) said Tuesday.
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Could Dogs Live Longer? Breakthrough Pill Receives Key Regulator Approval
FDA could allow the drug into the market, as soon as next year, once Loyalhits certain safety and manufacturing milestones.
-
Elon Musk's Neuralink Gets Go Ahead For Brain Chip Implant In 2nd Patient: Report
The US health regulator has allowed billionaire Elon Musk's Neuralink to implant its brain chip in a second person after it proposed to fix a problem that occurred in its first patient, the Wall Street Journal reported on Monday.
-
1st Over-The-Counter Birth Control Pill Approved In US
The US drug regulator approved the first over-the-counter birth control pill in the country, it announced Thursday, dramatically widening access to contraception for women as the United States grapples with reproductive rights.
-
US Makes New Alzheimer's Drug More Widely Accessible
The US drug regulator gave full approval to a new Alzheimer's medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly.
-
"No Contamination Found": Tamil Nadu Official As US Flags Indian Eye Drop
Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by Chennai-based Global Pharma, which has hit headlines after a US watchdog linked cases of infections, blindness and even deaths to the eye drops.
-
US Health Regulator Lists 378 Hand Sanitisers Consumers Should Not Use
Amid rising COVID-19 cases in China, the US Food and Drug Administration (FDA) released a list of hand sanitisers it recommends avoiding.
-
"Drug Products Adulterated": US Regulator Warns Sun Pharma's Gujarat Plant
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.
-
LASIK Patients Should Be Warned of Risks Before Eye Procedure, Says US Health Regulator
LASIK - Laser-Assisted In Situ Keratomileusis - is the most commonly performed laser refractive surgery used to correct common vision problems. However, the surgery is now under the lens of the US Food and Drug Administration (FDA).
-
Pharma Firm Lupin Gets US Regulator Nod For Generic Drug To Treat Cancer
Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America.
-
US Experts Recommend Novavax COVID-19 Vaccine
A panel of experts convened by the US drug regulator on Tuesday recommended the Novavax Covid-19 shot, a late runner in the fight against the virus that could nonetheless play a role in overcoming vaccine hesitancy.
-
US Health Regulator Lifts Hold On Covaxin's Clinical Trials
The US Food and Drug Administration which has put on hold phase 2/ 3 clinical trials of Bharat Biotech's COVID-19 vaccine Covaxin, in USA, has lifted pause, according to a statement issued by Ocugen Inc, Bharat Biotech's partner for jab in US, Canada
-
Moderna Seeks Emergency Approval For Second Covid Booster For US Adults
Moderna announced Thursday it had asked the United States drug regulator for emergency authorization for a second booster shot of the company's Covid-19 vaccine for all adults.
-
US Is Considering Second Covid Booster For 65+
Pfizer and BioNTech announced Tuesday they had formally asked the United States drug regulator for emergency approval of a second booster shot of their Covid vaccine for people aged 65 and older.
-
US Health Regulator Clears Covaxin For Clinical Trials In Adults In America
Bharat Biotech's COVID-19 vaccine Covaxin has been given clearance for clinical trials in adults by the US Food and Drug Administration (FDA).
-
For Omicron, Rapid Covid Tests Not As Accurate: US Regulator
Rapid Covid home tests are more likely to give a false negative with the heavily-mutated Omicron variant compared to earlier strains, the US Food and Drug Administration (FDA) said Tuesday.
