Musculoskeletal Disorders

UK MHRA approves new formulation of Amgen’s XGEVA

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for a new formulation of Amgen’s XGEVA…

Biogen receives EMA CHMP recommendation for ALS drug Qalsody

Biogen has received a positive opinion from the European Medicines Agency (EMA) committee recommending approval for Qalsody (tofersen) to treat…

PepGen earns FDA fast track designation for myotonic dystrophy type 1 candidate

The US Food and Drug Administration (FDA) has granted fast track designation to PepGen’s candidate for the treatment of myotonic…

FDA grants fast track status to Edgewise’s Duchenne treatment

The US Food and Drug Administration (FDA) has granted fast track designation to Edgewise Therapeutics’ investigational drug, EDG-5506, for Duchenne…

BridgeBio and Kyowa Kirin partner for skeletal dysplasia treatment

BridgeBio Pharma has entered a strategic partnership with Kyowa Kirin, granting the latter an exclusive licence for the development and…

J&J touts success of nipocalimab in two rare disease trials

Johnson & Johnson (J&J) has announced positive topline results for nipocalimab in two rare disease indications - generalised myasthenia gravis…

Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status

The US Food and Drug Administration (FDA) has granted rare paediatric disease (RPD) designation for Tyra Biosciences’ TYRA-300, an oral…

Celltrion USA seeks FDA approval for CT-P47 biosimilar

Celltrion USA, the American subsidiary of the biopharmaceutical company Celltrion, has filed a biologics licence application (BLA) with the US…

Santhera’s Agamree becomes first approved treatment in UK for all DMD patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Santhera’s Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy…

Biogen fend off generics of MS drug Tecfidera in Europe until 2025

The EC has ruled in favour of Biogen and revoked the centralised marketing authorisations for generic versions of Tecfidera (dimethyl…

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