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AstraZeneca’s camizestrant ambitions stumble as FDA panel rejects novel oral SERD proposal

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An FDA expert panel on Thursday voted 6 to 3 against AstraZeneca’s proposal of using its oral SERD camizestrant in a novel first-line switch setting in HR-positive, HER2-negative metastatic breast cancer, dealing an early blow to the British pharma’s $5 billion peak sales plan.

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Celiac disease is entering a new era of therapeutic innovation

For the ~1 in 100 people living with celiac, the burden of disease extends far beyond their plate.

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For the ~1 in 100 people living with celiac, the burden of disease extends far beyond their plate.

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The commercial launch playbook: Team structure, readiness and execution

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Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.

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Despite FDA trial clearance, ibogaine metabolite won’t receive red carpet treatment

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DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.

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