Tag #Drug Approval

Showing 1 to 12 of 20 results

cnn.com
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FDA to Abandon Expert Panels for Drug Review

The FDA plans to reduce its reliance on outside expert panels for drug reviews, a move criticized for decreasing transparency and public scrutiny, citing redundancy and workload as reasons.

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36% Bias Score

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lemonde.fr
🌐 75% Global Worthiness
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France's HAS Rejects Accelerated Approval for Alzheimer's Drug Leqembi

France's Haute Autorité de santé (HAS) rejected accelerated approval for Biogen and Eisai's Alzheimer's drug Leqembi due to modest efficacy and concerning side effects, despite its EU approval and patient advocacy.

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cnn.com
🌐 85% Global Worthiness
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FDA Chief Medical Officer Resigns Amidst Political Pressure

Dr. Vinay Prasad, the FDA's chief medical and scientific officer, resigned after less than three months due to White House pressure and public criticism from right-wing activist Laura Loomer, following a recent FDA reversal on Sarepta's Elevidys drug shipments.

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arabic.euronews.com
🌐 85% Global Worthiness
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EMA Conditionally Approves Alzheimer's Drug Donanemab Under Strict Monitoring

The European Medicines Agency conditionally approved Eli Lilly's Donanemab for early-stage Alzheimer's patients with one or zero copies of a specific gene, reversing its initial rejection due to the risk of fatal brain swelling and bleeding, mirroring a similar approval process for Lecanemab.

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europe.chinadaily.com.cn
🌐 85% Global Worthiness
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China Approves Novel Influenza Drug Onradivir

China approved Onradivir, a novel influenza A treatment targeting the PB2 protein, offering faster symptom relief and lower resistance potential than existing drugs like oseltamivir and baloxavir marboxil, potentially reducing the global burden of influenza.

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us.cnn.com
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FDA Appoints Covid-19 Vaccine Critic to Lead Biologics Division

The FDA appointed Dr. Vinay Prasad, a vocal critic of its Covid-19 policies, to head its Center for Biologics Evaluation and Research, replacing Dr. Peter Marks who resigned after criticizing HHS Secretary Robert F. Kennedy Jr. This appointment caused a 5% drop in biotech stocks and prompted concern...

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europe.chinadaily.com.cn
🌐 85% Global Worthiness
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Sanofi's Tzield Approved in China for Type 1 Diabetes Prevention

Sanofi's Tzield, an injection delaying type 1 diabetes progression, received approval in China, offering a three-year delay to stage 3 for eligible patients, impacting 600,000 individuals.

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us.cnn.com
🌐 85% Global Worthiness
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FDA Official Resigns Amidst Political Pressure

Dr. Vinay Prasad, the FDA's head of the Center for Biologics Evaluation and Research, resigned after less than three months due to White House pressure and public criticism from right-wing activist Laura Loomer, who accused him of being a "progressive leftist saboteur".

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es.euronews.com
🌐 85% Global Worthiness
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EMA Reverses Alzheimer's Drug Block, Approves Donanemab Under Strict Protocols

The European Medicines Agency (EMA) reversed its decision to block Donanemab, a new Alzheimer's treatment, approving it for early-stage patients with at most one copy of a specific gene under strict safety protocols after initially deeming the risks outweighed the benefits; Donanemab slows Alzheimer...

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theguardian.com
🌐 85% Global Worthiness
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FDA Rejects Promising Drug for Rare Mitochondrial Diseases

The FDA rejected elamipretide, a drug showing promise for treating rare mitochondrial diseases like MLS syndrome, despite positive patient testimonials and an advisory committee's narrow recommendation, raising concerns about the future of drug development for ultra-rare conditions.

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bbc.com
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Wales Rolls Out Cancer Drug Doubling Survival Time

The NHS in Wales now provides capivasertib, a new breast cancer drug shown to double life expectancy for half of women with oestrogen-fueled breast cancer when combined with hormone therapy; developed by Velindre Cancer Centre and Cardiff University, it's a significant advancement offering extended ...

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dw.com
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EU Approves Lecanemab for Early-Stage Alzheimer's; Strict Criteria Apply

The European Commission approved Lecanemab, a new Alzheimer's drug targeting amyloid plaques, for patients with minimal cognitive impairment and low ApoE4 gene copies; it offers a five-month delay in cognitive decline but is restricted due to potential side effects.

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36% Bias Score

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Showing 1 to 12 of 20 results