The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and prenatal screenings. ProPublica previously reported how lab-test accuracy and marketing had skirted federal oversight.
Ten doctors on FDA panel reviewing Abbott heart device had financial ties with company
When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.
BI exec underscores what FDA approval of Spevigo means for GPP care
With approval in hand, Boehringer Ingelheim is now pivoting its efforts to educating patients, healthcare providers and prescribers as well as increasing awareness of GPP in general.
Merck’s Winrevair earns FDA approval in milestone moment for PAH treatment
The FDA approval marks a milestone for Merck, which acquired the pulmonary arterial hypertension treatment in 2021 through its $11.5 billion buyout of Acceleron Pharma.
FDA’s updated RWE guidelines allow pharma marketers to make more claims
The Duvyzat approval came nine months after the FDA greenlit Sarepta Therapeutics’ Elevidys under the accelerated approval pathway, the first gene therapy to treat DMD.
FDA surprises Eli Lilly with adcomm for Alzheimer’s drug donanemab
The release of added context on the benefit-risk profile of CAR-T therapies underscores how safety is moving from the periphery into the category’s forefront.