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Tag: U.S. Food and Drug Administration

New York AG James sues to stop chlorpyrifos pesticide spraying on...

“Chlorpyrifos is extremely dangerous, especially to the health of our children,” the state attorney general said.

CT and NY AGs seek FDA input for marketing guidelines on...

"Companies are creating a myriad of cannabinoid products largely unburdened by any oversight or testing requirements," the attorneys general warned.

FDA cites Blue Buffalo and 15 other brands that might be...

However, the FDA did not call for any of the dog food products to be recalled.

U.S. Sen. Blumenthal slams Kim Kardashian West over detox tea endorsements

The senator warned that the reality television icon was "a powerful influence on young women."

IBM tapped for FDA blockchain pilot program on prescription tracking

"Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain," IBM's Mark Treshock said.

NY and CT AGs seek expanded FDA action on e-cigarettes

The attorneys general are part of a seven-state coalition urging the U.S. Food and Drug Administration to expand it scheduled enforcement actions against the sale of e-cigarettes.

FDA grants generic therapy designation for Purdue Pharma’s opioid overdose treatment

Purdue Pharma's Craig Landau said the company wants to make this treatment "available as broadly and quickly as possible."

FDA fast-tracks Intensity Therapeutics’ breast cancer treatment

“Finding improved therapies for this disease is a critical unmet medical need,” said Lewis H. Bender, president and CEO of Intensity Therapeutics.

Imbrium Therapeutics receives FDA orphan drug designation for biliary tract cancer...

Roughly 8,000 people in the U.S. are diagnosed with biliary tract cancer each year.

New insomnia drug from Purdue Pharma submitted to FDA

According to the companies, lemborexant is designed to regulate the sleep-wake cycle by dampening wakefulness without impeding the ability to awaken to external stimuli.

Stamford’s Loxo Oncology receives FDA approval on cancer drug

"The approval of Vitrakvi is a testament to the relentless prioritization of biology in the drug development process," said Josh Bilenker, CEO of Loxo Oncology.

FDA fast tracks SpringWorks Therapeutics drug for treatment of tumors

"The fast track designation recognizes that desmoid tumors have a substantial impact on the lives of patients," said Saqib Islam, CEO of SpringWorks Therapeutics.

FDA clearance for Westport-based Lumendi’s surgical device

The product is a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.

U.S. Sens. Blumenthal and Murphy seek allergen labeling for sesame

“Accurate, uniform, and comprehensive allergen labeling is essential to enable allergy sufferers to avoid specific ingredients and potentially fatal reactions,” the senators stated.

Loxo Oncology completes rolling submission of new drug application for larotrectinib

Stamford-based Loxo Oncology Inc has announced its completion of the rolling submission of a new drug application to the U.S. Food and Drug Administration for the TRK inhibitor treatment larotrectinib.