Us Fda

Lupin gets US FDA nod for its first biosimilar drug Pegfilgrastim

The product, a biosimilar to Amgen's popular drug Neulasta, will be manufactured at Lupin's biotech facility in Pune

USFDA's new biosimilar norms to woo more players, fast-track mkt entry

Indian cos like Biocon, DRL, Intas, Lupin stand to benefit from the proposed move

Cough syrups linked to child deaths in India not shipped to US, says FDA

The US FDA said it was aware of news reports of devastating, ongoing diethylene glycol and ethylene glycol contamination in children's cough and cold medicine in India

Uttarakhand launches statewide crackdown on sale of banned cough syrups

Following the advisory issued by the Central Government, the state has appealed to doctors not to prescribe banned cough syrups for children

Lupin gets US FDA nod for generic drug Lenalidomide in multiple potencies

The announcement comes a day after Lupin said the US FDA had inspected its Nagpur injectable facility between September 8 and 16, issuing six observations

US FDA clears Apple Watch feature rollout for hypertension detection

Apple said the new hypertension notification feature will be available on Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models before the end of September

Apple Watch's hypertension detection feature gets US FDA approval: Report

Apple secures FDA approval for its hypertension detection feature, reportedly set to roll out next week on eligible Apple Watch models, including Series 9, 10, 11, Ultra 2, and Ultra 3

Sun Pharma's Halol plant gets OAI classification from US FDA inspection

US FDA has classified Sun Pharma's Halol facility in Gujarat as OAI, keeping it under import alert, signalling possible enforcement action unless corrective steps are taken

US FDA announces new program to boost domestic drug manufacturing

The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements, the FDA said

Aurobindo Pharma recalls over 4,600 bottles of painkiller in US market

The drug, Acetaminophen Tablets (325 mg), is being recalled due to manufacturing deviations from Current Good Manufacturing Practices, following complaints of brown tablet discolouration

US FDA to fast-track drug reviews for firms backing national priorities

US regulators will begin offering faster reviews to new medicines that administration officials deem as promoting the health interests of Americans, under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to challenge assumptions and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of national priority vouchers to companies aligned with U.S. national priorities,

US FDA approves Moderna's new lower-dose Covid-19 vaccine 'mNexspike'

The US approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose a fifth of the dose of its current COVID-19 vaccine, Spikevax by refining its immune target. The approval adds an important new tool to help protect people at high risk of severe disease from COVID-19, Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the US has handled COVID-19 vaccines until now, reflecti

FDA may change Covid-19 booster rules from 2025: What it means for you

The US Food and Drug Administration may limit Covid-19 boosters shots to high-risk groups from 2025; Pfizer reviewing proposal as agency seeks new trials, clearer risk labels for younger males

Alzheimer's diagnosis with blood test becomes reality: All you need to know

Lumipulse G pTau217/ß-Amyloid 1-42: USFDA has approved the first-ever blood test to help diagnose Alzheimer's disease, offering a faster, less invasive, and more affordable way to detect early signs

First blood test for Alzheimer's in US from June, starting at 50 hospitals

The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain

US FDA approves Novavax Covid vaccine with added conditions for use

According to the approval letter, the license restricts the use of the vaccine called Nuvaxovid to individuals aged 65 and older, and those between 12 and 64

Biocon Biologics secures multiple market access coverage for Yesintek in US

Biocon Biologics' biosimilar Yesintek is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, and promises a cost-effective treatment

US govt will work with food makers to stop use of artificial dyes

Food and Drug Administration Commissioner Marty Makary said Tuesday that the agency would work with the industry to eliminate six synthetic dyes by the end of 2026

US FDA workers brace for mass layoffs amid health services job cuts

As they readied to leave work Monday, some workers at the Food and Drug Administration were told to pack their laptops and prepare for the possibility that they wouldn't be back, according to an email obtained by The Associated Press. Nervous employees roughly 82,000 across the nation's public health agencies waited to see whether pink slips would arrive in their inboxes. The mass dismissals have been expected since Secretary Robert F. Kennedy Jr. announced last week a massive reorganization that will result in 20,000 fewer jobs at the Department of Health and Human Services. About 10,000 will be eliminated through layoffs. The email sent to some at the FDA said staffers should check their email for a possible notice that their jobs would be eliminated, which would also halt their access to government buildings. An FDA employee shared the email with AP on condition of anonymity, because they weren't authorized to disclose internal agency matters. Kennedy has criticized the ...

US FDA approves GSK's 'Blujepa' for treating UTIs in women and girls

The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s