#drug-approval

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#fda

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

The FDA's decision to change a prior ruling alleviated patient access issues but raised safety concerns regarding compounded drugs.

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions - MedCity News

The FDA made significant regulatory approvals, notably the first drug for obstructive sleep apnea and a groundbreaking cell therapy for graft vs host disease.

The Future of Psychedelic Research Is In Limbo - Why the FDA's Decision Changed Everything

The FDA declined Lykos Therapeutics' MDMA-assisted therapy application, signaling challenges for psychedelic drug approval.

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

The FDA's decision to change a prior ruling alleviated patient access issues but raised safety concerns regarding compounded drugs.

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions - MedCity News

The FDA made significant regulatory approvals, notably the first drug for obstructive sleep apnea and a groundbreaking cell therapy for graft vs host disease.

The Future of Psychedelic Research Is In Limbo - Why the FDA's Decision Changed Everything

The FDA declined Lykos Therapeutics' MDMA-assisted therapy application, signaling challenges for psychedelic drug approval.
morefda

Richard Pazdur, FDA Cancer Chief, Discusses 25 Years of Innovation

Cancer treatment has evolved significantly over the past 25 years, enabling more targeted therapies and improved patient outcomes.
#european-medicines-agency

Europe sidelines Alzheimer's drug: lessons must be learnt

The EMA's cautious approach may deny patients access to effective Alzheimer's treatment, contrasting with global acceptances of lecanemab.

A scientific rebellion to get Europe to approve a controversial Alzheimer's drug

Lecanemab represents a breakthrough for Alzheimer's treatment but faces significant controversy regarding its efficacy, safety, and accessibility.

Europe sidelines Alzheimer's drug: lessons must be learnt

The EMA's cautious approach may deny patients access to effective Alzheimer's treatment, contrasting with global acceptances of lecanemab.

A scientific rebellion to get Europe to approve a controversial Alzheimer's drug

Lecanemab represents a breakthrough for Alzheimer's treatment but faces significant controversy regarding its efficacy, safety, and accessibility.
moreeuropean-medicines-agency

Ex-NYC COVID czar details in secret recording how to use media to 'spin' monkeypox drug stories

Dr. Jay Varma's comments suggest manipulative media tactics were utilized to gain FDA approval for a drug with questionable efficacy.
#alzheimers-disease

Lilly's Alzheimer's drug faces delayed reckoning

FDA advisers are reviewing Eli Lilly's Alzheimer's drug application, impacting future treatments targeting amyloid plaques.

First drug to slow Alzheimer's too costly for NHS

NICE has decided against funding lecanemab on the NHS, citing insufficient benefits relative to the treatment costs.

Biogen Abandons Its Controversial Alzheimer's Drug Aduhelm

Biogen is abandoning its ownership rights to the Alzheimer's drug Aduhelm, after it failed to gain traction in the market.
The decision to abandon Aduhelm comes after the drug faced criticism for its weak evidence of efficacy, high price, and safety risks.

Lilly's Alzheimer's drug faces delayed reckoning

FDA advisers are reviewing Eli Lilly's Alzheimer's drug application, impacting future treatments targeting amyloid plaques.

First drug to slow Alzheimer's too costly for NHS

NICE has decided against funding lecanemab on the NHS, citing insufficient benefits relative to the treatment costs.

Biogen Abandons Its Controversial Alzheimer's Drug Aduhelm

Biogen is abandoning its ownership rights to the Alzheimer's drug Aduhelm, after it failed to gain traction in the market.
The decision to abandon Aduhelm comes after the drug faced criticism for its weak evidence of efficacy, high price, and safety risks.
morealzheimers-disease

Daily briefing: Millions of mosquitos deployed to save Hawaii's birds

Memories might be formed in the primary visual cortex, not just the eyes.

Daily briefing: 'I had no choice but to commit misconduct'

Elephants use proper names to address each other, a behavior unique to humans.
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