The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...

In a new First Opinion essay, Borio and Krause, both once top FDA officials, say the commissioner made a “rookie misstep” in ...

unsuccessful applicants can follow the instructions provided in the decision letter that outlines whether they can contest the decision. If eligible, they will initiate the process with mandatory ...

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio ...

Proprio received a previous 510(k) clearance from the FDA in 2023. The company declined to share revenue metrics. The much-anticipated and hotly-contested GeekWire Awards celebrate the top ...

As KalVista Pharmaceuticals awaits an FDA decision on its hereditary angioedema (HAE) treatment sebetralstat, the company has sold the Japanese rights to the drug to Kaken Pharmaceutical for $11 ...

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® ...

We encourage readers to express their views about public issues. Letters to the editor are subject to editing for brevity and clarity. Limit letters to 200 words (100 words if endorsing or ...

This will also outline the issues and pertinent information for FDA decision-makers who, due to increased demands, cannot attend in person. It can also be useful to convey the future value of a ...

In Jason Williams’ column in Friday's paper ("Welcome back, Thom Brennaman," April 4), I read that Thom Brenneman was hired to replace Mike McConnell for the morning talk slot on WLW radio ...

No matter your political or religious choices, you must realize that our current American democracy is being dismantled before our eyes. Daily, we are experiencing the chipping away at the ...