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- PMLiVE

Dupixent

- PMLiVE

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

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

- 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

- PMLiVE

Merck KGaA and Aqilion AB partner in potential €960m deal

The companies will work together to develop small molecule inhibitors of the TAK1 protein

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

Sanofi’s enzyme replacement therapy available on NHS to Pompe disease patients

The rare genetic disorder affects around one in every 40,000 people in the UK

- 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

Sanofi/Regeneron’s Dupixent approved by EC for eosinophilic oesophagitis

This makes Dupixent the first and only targeted medicine indicated for this condition

- PMLiVE

Sanofi/Regeneron’s Dupixent recommended by CHMP for atopic dermatitis in children

If approved, the medicine would be the first and only targeted option in the EU for this age group

- 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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