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FDA Fast Talk: Health Advisories with Unclear Advice

 
• By Ramsey Baghdadi

FDA is trying to get safety messages out to consumers more rapidly. A recent warning on Nexium and Prilosec shows how complicated these early warnings can be.

What happens when FDA makes an announcement about a possible health issue but really doesn’t have anything to say? FDA’s recent review of AstraZeneca PLC ’s esomeprazole (Nexium) underscores exactly how squeezed the agency is right now.

On August 9, FDA put out a health advisory and scheduled a media call with associate director for safety policy...

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Delese Mimi Darko Appointed To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
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The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
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CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

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Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
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New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.