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All Stories: FDA

US FDA approves Juul’s tobacco and menthol e-cigarettes

July 17, 2025: Juul Labs said on Thursday the US Food and Drug Administration (FDA) has authorized the sale of its e-cigarette device and...

Nucala: Drug wins approval to treat ‘smoker’s lung’

The U.S Food and Drug Administration has approved Nucala, British drugmaker GSK's asthma drug, to treat some patients with a chronic lung disease commonly...

US FDA declines to approve first MDMA-based PTSD treatment

The U.S. FDA has declined to approve a therapy based on the mind-altering drug MDMA for patients with post-traumatic stress disorder (PTSD), stating it...

Dupixent: US approves medicine to treat younger kids with esophageal condition

The US health regulator has approved the use of Regeneron and Sanofi's Dupixent to treat an allergic inflammation of the esophagus in children aged...

Consumer group seeks stronger warnings on Botox

Consumer advocacy group Public Citizen on Tuesday filed a petition with the U.S. Food and Drug Administration seeking to require makers of Botox and...

US FDA authorizes Pfizer and Moderna’s updated COVID vaccines

The US Food and Drug Administration (FDA) on Monday authorized updated COVID-19 vaccines from Pfizer/BioNTech and Moderna that target a recently circulating Omicron variant...

US FDA approves Mirati’s lung cancer drug

The US Food and Drug Administration approved Mirati Therapeutics Inc’s (MRTX.O) lung cancer drug adagrasib, the company said on Monday, sending its shares up...

US FDA advisers weigh Moderna COVID vaccine heart risk for young men

WASHINGTON: Moderna's COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer/BioNTech shot, according to data presented on...

US authorizes Pfizer oral COVID-19 treatment, first for at-home use

WASHINGTON: The United States on Wednesday authorized Pfizer Inc's (PFE.N) antiviral COVID-19 pill for people ages 12 and older at risk of severe illness,...

US aims to give full approval to Pfizer vaccine on Monday: report

The US Food and Drug Administration is aiming to give full approval to Pfizer's COVID-19 vaccine on Monday, the New York Times reported on...

US authorizes COVID-19 vaccine boosters for the immunocompromised

The US Food and Drug Administration on Thursday authorized a booster dose of COVID-19 vaccines from Pfizer and Moderna for people with compromised immune...

US aiming to give full approval to Pfizer vaccine by early next month: report

The US Food and Drug Administration is aiming to give full approval for the Pfizer COVID vaccine by early September, the New York Times...

US set to authorize Pfizer COVID-19 vaccine for ages 12-15

An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial

Coronavirus variants may lead to false negative results

The U.S. drugs regulator said on Friday genetic variants of COVID-19, including the one found in the UK, could lead to false negative results from some molecular COVID-19 tests.

US authorizes Moderna COVID-19 vaccine

Moderna’s coronavirus vaccine on Friday became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration

US FDA authorizes Pfizer COVID-19 vaccine for emergency use

Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses this month.

FDA approves first COVID-19 test kit for home use

'While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home'

Trump hails FDA’s authorization of plasma treatment for coronavirus, after slamming agency

The FDA, explaining its decision, cited early evidence suggesting blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization.

FDA gives anti-malaria drugs emergency approval to treat coronavirus

The US has more than 140,000 novel coronavirus cases and 2,489 deaths, according to a tracker maintained by Johns Hopkins University.

Fish-oil derived therapy for reducing heart attack risk gets approval

US health regulators approved expanding the heart benefit claims Amarin can make in promoting its drug Vascepa to include reducing the risk of heart attacks
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