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.
FDA repeatedly rejected safety claims made by Philips after the CPAP recall but waited to alert the public, emails show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.
FDA’s plan to ban hair relaxer chemical called too little, too late
In April the Food and Drug Administration is tentatively scheduled to unveil a proposal to consider banning the chemical in hair-straightening products.