MPR21h
FDA Drug Approval Decisions Expected in May 2025
The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.
Amgen gets expanded FDA label approval for Uplizna
Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...
Amgen announces FDA approval of Uplizna
Amgen (AMGN) announced that the U.S. FDA has approved Uplizna as the first and only treatment for adults living with Immunoglobulin G4-related ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
News-Medical.Net1d
What Happens When Drugs Fail Post-Approval?
This article examines post-market drug safety, highlighting surveillance mechanisms, regulatory responses, and case studies of approved drugs with hidden risks.
FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
Supreme Court upholds FDA decision to ban flavored vapes
The Supreme Court on Wednesday threw out an appeals court ruling that found the FDA unlawfully handled approval requests made ...
Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could ...
Supreme Court largely backs Biden-era FDA on flavored vapes
The US Supreme Court largely sided with the Food and Drug Administration in its rejection of applications to sell flavored ...
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
Unanimous Supreme Court upholds FDA block of flavored vapes
The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...