With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...

The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...

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, ...

A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...

On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and ...

or whether NHS R&D and NHS REC approval is required, and seek guidance from them as to the subsequent application process. The NICR panel meets regularly throughout the year to consider ethical ...

driven by increased demand for IntelliSep®, the company's U.S. Food and Drug Administration (FDA)-cleared rapid sepsis detection solution. In the first full year of commercialization, Cytovale ...

The process to evaluate MRD as an intermediate ... endpoint—is required for regular FDA approval of a new drug. Treatments for serious or life-threatening illnesses may be granted accelerated approval ...