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FDA takes action to grant traditional approval of Leqembi™ (lecanemab, Eisai/Biogen) for the treatment of early Alzheimer’s disease with confirmation of elevated amyloid beta. This is the first traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease.
Continue readingThe FDA announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingSuperior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids.
Continue readingThe FDA approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.
Continue readingThe FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
Continue readingThe FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist.
Continue readingIn adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization or approved by the FDA, an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine.
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