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Sarepta Therapeutics

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FDA grants priority review for traditional approval of Biogen and Eisai’s Alzheimer’s drug

Leqembi was granted accelerated approval in the US earlier this year

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Pfizer’s RSV vaccine candidate for older adults backed by FDA Advisory Committee

RSV infections in older adults account for 60,000 to 160,000 hospitalisations each year in the US

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FDA authorises first at-home COVID-19 and flu test for emergency use

The single-use test uses nasal swab samples and provides results in about 30 minutes

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Sanofi and Sobi’s once-weekly haemophilia A treatment approved by FDA

Current factor VIII therapies usually require patients to receive treatment every two days

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Pfizer’s maternal RSV vaccine candidate accepted for FDA priority review

Globally, RSV infections cause over 100,000 child deaths annually

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FDA external report recommends actions to address US opioid crisis

Over 100,000 Americans died from a drug overdose in 2021, with 70,000 of those due to opioids

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FDA panel backs over-the-counter use of Emergent BioSolutions’ Narcan

The nasal spray works by blocking the effects of an opioid overdose if administered in time

Biogen Idec building

Safety-related change to label for Biogen’s Alzheimer’s drug Aduhelm approved by FDA

Larger areas of bleeding on the brain have been reported in some patients taking the drug

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FDA gives orphan drug status to Avidity’s rare muscular dystrophy treatment

There are currently no approved treatments for patients living with the disease

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Sandoz’s biosimilar denosumab application accepted by FDA for osteoporosis

More than ten million adults in the US alone over the age of 50 are estimated to have the condition

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GSK’s Benlysta given orphan drug status by FDA for systemic sclerosis

The rare autoimmune disease affects two to ten people per million and has limited treatments

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Tidepool’s automated insulin dosing app for type 1 diabetes gets FDA approval

Tidepool Loop is the first app of its kind to receive clearance in the US

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