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- PMLiVE

Beta thalassaemia

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

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

- PMLiVE

BeiGene’s Brukinsa receives FDA approval for chronic lymphocytic leukaemia

The BTK inhibitor demonstrated better results than Imbruvica, a standard of care treatment in CLL

- PMLiVE

Eli Lilly’s Alzheimer’s drug denied FDA accelerated approval

The FDA said there was not enough trial data from patients who were treated for at least a year

- PMLiVE

Novo Nordisk’s type 2 diabetes drug approved by FDA as first-line option

Rybelsus was initially approved in 2019 as a second-line treatment

- PMLiVE

FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine

Preliminary data showed a possible link between the updated vaccine and a higher risk of stroke

- PMLiVE

AstraZeneca and Avillion’s asthma rescue treatment granted FDA approval

Airsupra significantly reduces the risk of severe asthma exacerbations

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