studyfinds10d
Alzheimer’s drug breakthrough or breakdown? Investigation exposes red flags in FDA approval of donanemab
A startling investigation has revealed a troubling story behind donanemab's approval -- one of questionable data, potential ...
Critical Flaws: New Alzheimer’s Drug Could Actually Be a Safety Risk
An investigation has uncovered alarming issues including increased mortality rates, absent safety records, dubious efficacy, ...
pharmaphorum21d
FDA blocks early nod for Lilly's Alzheimer's drug donanemab
Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer's ... donanemab." While the phase 2 TRAILBLAZER-ALZ trial included more than 100 patients on the drug ...
FDA Approves the First New Schizophrenia Drug in Decades
Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb, the drug works in an entirely ...
pharmaphorum16d
Lilly’s Alzheimer’s drug delayed as FDA seeks adcomm
The FDA has said it will seek the ... review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug. Lilly said the US regulator “wants ...
FDA approves first new drug for schizophrenia in more than 30 years
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to ... Studies for additional therapeutic ...
McKnight's Long-Term Care News9d
Journalists question safety and effectiveness of new Alzheimer’s drug
A report published Wednesday in The BMJ questioned the safety and effectiveness of the Alzheimer’s disease drug Kisunla ...
STAT4d
After Cassava Alzheimer’s drug fiasco, the FDA must intervene to protect patients
The SEC concluded that Cassava Sciences falsified data in its Alzheimer’s clinical trials. Now the FDA needs to act, ...
Los Angeles Times18d
FDA approval of Kisunla brings change to Alzheimer’s
The U.S. Food and Drug Administration (FDA) has taken a move in the management of Alzheimer’s disease by approving a drug known as Kisunla (donanemab-azbt). Kisunla focuses on patients diagnosed with ...
朝日新聞社3d
US approves Alzheimer’s drug that modestly slows disease
Last week, a congressional report found that FDA's approval of a similar Alzheimer's drug called Aduhelm — also from Biogen and Eisai — was “rife with irregularities,” including a number ...
Yahoo Finance19d
Lilly Gets FDA Approval for Eczema Drug Ebglyss
Eli Lilly and Company LLY announced that the FDA ... (donanemab) for treating early symptomatic Alzheimer's disease. Lilly believes Kisunla can generate blockbuster sales. Kisunla is only the ...
FDA Approves New Schizophrenia Drug in 70-Year First
The treatment offers hope to thousands of patients who do not respond to existing medications, and has shown promise in treating other neurological disorders.