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BioXcel gets first approval for agitation drug Igalmi

BioXcel Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with schizophrenia or bipolar disorder.

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NICE reverses stance on Merck's Bavencio for bladder cancer

Last year, NICE said that Merck KGaA/Pfizer's Bavencio was too expensive for routine in NHS use as a first-line maintenance treatment for bladder cancer, even though the drug is the only ca

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NICE ends UK access disparity to osteoporosis drug Evenity

NICE has reversed its stance on UCB and Amgen's severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the disease in England and Wales who are at high

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Patients dismayed as FDA advisors narrowly reject Amylyx' AL...

By a narrow margin, an FDA advisory committee has voted against approval of Amylyx' experimental medicine for amyotrophic lateral sclerosis until the company can provide more evidence that

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Amylyx slumps on non-committal FDA reviewer assessment of AL...

Shares in Amylyx Pharma slid today after the FDA published a less-than-enthusiastic assessment of its amyotrophic lateral sclerosis (ALS) therapy ahead of an advisory committee meeting on W

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FDA restricts GSK's Xevudy due to lower efficacy against BA....

GlaxoSmithKline and Vir's Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus.

BioXcel gets first approval for agitation drug Igalmi

NICE reverses stance on Merck's Bavencio for bladder cancer

NICE ends UK access disparity to osteoporosis drug Evenity

Patients dismayed as FDA advisors narrowly reject Amylyx' AL...

Amylyx slumps on non-committal FDA reviewer assessment of AL...

FDA restricts GSK's Xevudy due to lower efficacy against BA....

FDA starts review of Regeneron's drug for rare disease FOP

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