The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

The combined entity will offer a unique mix of proprietary market-cleared technologies, and development and manufacturing scale, that will enable its OEM customers to achieve unmatched speed to market ...

A bill has been introduced in New York that would require collision repair shops to disclose to vehicle owners the types of ...

BASF Coatings has partnered with BMW Group, designating its premium paint brands, Glasurit and R-M, as preferred options for BMW’s aftersales n ...

The deal does not include a provision to raise the debt limit. After days of heated negotiations on Capitol Hill and eleventh-hour interference from President-elect Donald Trump and his ally Elon ...

Bolt Brands, LLC; a Delaware-based corporation, will feature carrier-agnostic connectivity products built for small businesses and focused on ease of use and world-class customer support. The new ...

Designates are the five Directors of Community Planning in each planning district. There is a two-stage approval process for Site Plans. The first stage is the issuance of the Notice of Approval with ...

Shelby Knowles/Bloomberg via Getty The weight loss drug Zepbound, generically known as tirzepatide, is also now an approved medication to treat obstructive sleep apnea, per a Food and Drug ...

President Nana Addo Dankwa Akufo-Addo has granted approval for visa-free travel to ... ensuring visa-free travel for all Africans, and the process has begun to implement the policy this year ...

One of the most common pieces of tech has been given a massive new dimension with the approval of life-changing technology in Australia. Each country’s medicines regulator has been required to ...