US FDA

A Nevada-based biopharmaceutical company Corstasis Therapeutics has received approval from the US Food and Drug Administration for the bumetanide nasal spray, which could be useful in the treatment of edema associated with heart, liver, and kidney diseases.

FDA approves first nasal spray diuretic for heart, liver and kidney disease

The US FDA has approved the first-ever nasal spray diuretic for heart, liver, and kidney disease patients for the treatment…

September 17, 2025 13:42 IST

FDA approves new COVID vaccine shots for 2025-2026: Here’s who is eligible and what you need to know

The FDA has approved new COVID-19 vaccines for 2025-2026. Here’s a simple guide on who can get them, how they…

September 9, 2025 19:18 IST

FDA flags sale of Indian cookware brand, Here’s what lead leaching can do to you

The US FDA flagged THIS brand for lead leaching from utensils. Check what it does to your body.

August 22, 2025 14:44 IST

Sun Pharma launches LEQSELVI in US for severe hair loss

Sun Pharma launches key alopecia drug in US, experts estimate $200–300 million market potential

Updated: July 15, 2025 14:30 IST

Sun Pharma, pharma industry, Dilip Shanghvi, USFDA, manufacturing, compliance issues, US FDA inspection, R&D spend, revenue, specialty revenue

Sun Pharma steps up USFDA compliance drive: What’s changing at Halol, Mohali and Dadra?

Sun Pharma is stepping up regulatory compliance efforts at three USFDA-flagged facilities, including Halol, Mohali, and Dadra.

July 8, 2025 11:07 IST

Drug maker Lupin on Monday said its subsidiary has inked a pact to fully acquire Amsterdam-headquartered VISUfarma BV

Lupin gets US FDA nod for constipation drug Prucalopride tablets

Lupin has received USFDA approval for its ANDA for Prucalopride Tablets, used to treat Chronic Idiopathic Constipation in adults.

Updated: June 25, 2025 15:13 IST

Is the Halol hurdle too high for Sun Pharma? 4 reasons why Nomura sees limited upside potential

Sun Pharma’s Halol issues limit potential; Nomura sees a 17% upside. Stay updated on regulatory developments at Halol facility.

June 17, 2025 12:34 IST

Sun Pharma, pharma industry, Halol facility, inspection, US FDA, Good Manufacturing Practices, import, leadership change, managing director, appointment

Compliance review: US FDA issues 8 observations for Sun Pharma’s Halol plant following GMP inspection

Sun Pharma said the US FDA issued a Form-483 with eight observations after inspecting its Halol facility from June 2–13.

Updated: June 16, 2025 10:13 IST

FDA approves Moderna next-generation COVID-19 vaccine

Moderna’s next-generation COVID-19 vaccine gets FDA nod for adults aged 65 and above

The shot is also cleared for individuals between 12 and 64 years of age who are at least one risk…

Updated: May 31, 2025 14:28 IST

us government, layoffs, us healt department, Donald trump, cdc, fda, Robert kennedy jr,

Trump govt begins mass layoffs at US health agencies, 10,000 workers to lose jobs amid restructuring

The layoffs — which will affect the CDC and FDA — have been hailed as an essential step by Health…

April 1, 2025 21:06 IST

Plastic in Coca-Cola: Over 10k cans recalled with 2nd-highest risk classification

Coca-Cola recall news affects more than 10,000 cans of the beloved beverage distributed in two American states.

March 27, 2025 11:30 IST

Zydus Lifesciences soars 3% on US FDA nod for manufacturing Apalutamide Tablets

Zydus Lifesciences share price today, March 19: Zydus soars on US FDA approval for Apalutamide tablets. Discover the impact!

March 19, 2025 14:51 IST

Divi's Laboratories, Pharmaceutical, pharma industry, Q2FY24 results, profit, revenue, EBITDA

Ajanta Pharma Q2 profit rises 24.7% to Rs 195.30 crore, revenue up 9.6% on-year

Ajanta Pharma posted revenue from operations at Rs 1,028.44 crore, up 9.6 per cent as against Rs 938.10 crore during…

October 31, 2023 15:02 IST

The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. (Representative image)

USFDA inspection of company’s US plant completed successfully: Torrent Pharmaceuticals

Form 483 is issued to a firm’s management at the conclusion of an inspection when an investigator has observed any…

December 16, 2021 16:42 IST

FDA publishes draft guidance on assessing adhesion with TDS and topical patches for ANDAs

Updated recommendations are provided for the statistical analysis of adhesion scores and results The FDA has published the draft guidance…

June 2, 2016 11:19 IST

Claris announces receipt of EIR from US FDA

The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015 Sterile injectables company; Claris Lifesciences…

May 30, 2016 16:59 IST

Lupin announces closure of US FDA audits for its Mandideep and Aurangabad facilities

The US FDA had conducted audits at Lupin’s Mandideep facility from February 8-19, 2016 and its Aurangabad facility from January…

May 27, 2016 11:41 IST

Indoco Remedies receives US FDA nod for Goa manufacturing facility

The approval confirms the closure of inspection conducted in July 2015

May 26, 2016 12:15 IST

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Bengaluru techie ‘killed’ by a pothole; was riding pillion, crushed by a truck

India News35 min ago

A 26-year-old techie, Priyanka Kumari Poonia, died in a tragic accident in Bengaluru. She was riding on a motorcycle with her brother on a damaged road when they fell due to a pothole. Priyanka, not wearing a helmet, was run over by a lorry and died. Police are investigating and her brother’s statement will provide more information.

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