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- PMLiVE

Accelerated approval

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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

- PMLiVE

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

- 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

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Ipsen to acquire worldwide rights to pre-clinical stage oncology programme

The company has an existing partnership with the Université de Montréal and IRICoR

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

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ICR discovery could lead to new series of cancer drugs

The team found new inhibitors that block the action of a cancer-driving protein

- 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

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Innovative Trials comments on extra funding to increase access to clinical trials for cancer patients

Kate Shaw, Innovative Trials' Founder & CEM, reflects on the exciting news for patients affected by cancer in the UK.

Innovative Trials

- 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

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