Us Fda

India extends lead over China in US FDA drug master filing in Q1FY26

Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership in API manufacturing and future generic drug development

US FDA flags data integrity, maintenance lapses at Dabur India plant

Dabur ​is one of India's oldest and largest consumer goods companies, describing itself ‌as one of the world's largest suppliers of Ayurvedic products with a legacy of over 140 years

Zydus eyes Q4 FY27 US launch for liver disease drug after FDA review

The US FDA has granted priority review to Saroglitazar, Zydus Lifesciences' drug for treating Primary Biliary Cholangitis

US FDA vaccines chief Vinay Prasad set to leave his post next month

FDA Commissioner Marty Makary thanked Prasad for his service in a post on X late Friday, noting his division hit a record number of approvals in December

FDA to act against companies selling 'illegal copycat drugs', chief says

Makary's comments came after online telehealth company Hims and Hers Health began offering a much cheaper $49 compounded version of Novo Nordisk's new Wegovy weight-loss pill

Popular weight-loss drugs shouldn't carry suicide warnings, FDA says

Federal regulators have told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviours from their blockbuster weight-loss medications. The US Food and Drug Administration on Tuesday said a comprehensive review found no increased risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that a small risk may exist. The new analysis puts those concerns to rest. Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted. Today's FDA action will ensure consistent messaging across the labelling for all FDA-approved GLP-1 RA medications, officials said.

Novo gets US nod for Wegovy pill, eyes January launch in obesity market

Novo will start selling the pill, the first of the blockbuster GLP-1 class, in the US in early January, the company said in a statement Monday

Sun Pharma shares slip 3% after US FDA flags Baska manufacturing facility

Sun Pharma's Baska plant in Gujarat receives OAI status from the US FDA after inspection, adding near-term regulatory uncertainty but not impacting current US supplies

Zydus Life's US arm gets FDA nod for Menkes disease drug resubmission

The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children

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,