Novartis' Entresto Patent Claims Revived by CAFCThe CAFC upheld the validity of Novartis' Entresto patent claims, emphasizing the importance of the written description standard and rejecting arguments for invalidity.
Drugmakers can keep making off-brand weight-loss drugs as FDA backpedalsThe 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 NewsThe 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 EverythingThe 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 backpedalsThe 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 NewsThe 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 EverythingThe FDA declined Lykos Therapeutics' MDMA-assisted therapy application, signaling challenges for psychedelic drug approval.
Richard Pazdur, FDA Cancer Chief, Discusses 25 Years of InnovationCancer treatment has evolved significantly over the past 25 years, enabling more targeted therapies and improved patient outcomes.
Europe sidelines Alzheimer's drug: lessons must be learntThe 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 drugLecanemab 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 learntThe 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 drugLecanemab represents a breakthrough for Alzheimer's treatment but faces significant controversy regarding its efficacy, safety, and accessibility.
Ex-NYC COVID czar details in secret recording how to use media to 'spin' monkeypox drug storiesDr. Jay Varma's comments suggest manipulative media tactics were utilized to gain FDA approval for a drug with questionable efficacy.
Lilly's Alzheimer's drug faces delayed reckoningFDA 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 NHSNICE has decided against funding lecanemab on the NHS, citing insufficient benefits relative to the treatment costs.
Lilly's Alzheimer's drug faces delayed reckoningFDA 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 NHSNICE has decided against funding lecanemab on the NHS, citing insufficient benefits relative to the treatment costs.
Daily briefing: Millions of mosquitos deployed to save Hawaii's birdsMemories 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.