NLS New Market

New Market - May 20, 2026

Lundbeck receives orphan drug designation in Japan 

The orphan drug designation has been granted for asedebart for the treatment of patients with congenital adrenal hyperplasia and Cushing’s disease.

MedTech Business - May 6, 2026

Encare sets its sights on the USA

When Encare was awarded the Swecare Export Award 2026, the company was highlighted as one of the Swedish healthtech companies that has succeeded in translating clinical research into concrete benefits in healthcare internationally.

Business article - April 7, 2026

Zealand Pharma establishes US Research Hub in Cambridge

The new research hub in Cambridge, Massachusetts, in the greater Boston area, will serve as Zealand Pharma’s primary US address and is expected to be operational from September 2026.

New Market - April 7, 2026

Immedica announces first marketing authorization approval in the MENA region

Immedica has announced that the Kuwait Ministry of Health (MOH) has granted Marketing Authorization (MA) approval for Ztalmy (ganaxolone) for the treatment of seizures associated with CDKL5 deficiency disorder (CDD) in Kuwait.

MedTech Business - February 16, 2026

FDA grants De Novo Classification request from Amferia

Amferia's antibacterial wound dressing has been granted approval by the US Food and Drug Administration (FDA) through the De Novo Classification Request track, allowing Amferia to enter the US market with a unique Class 2 medical device antibacterial dressing for advanced wound care.

Biotech Business - February 2, 2026

Alvotech enters supply and commercialization agreements for Canada and Australia & New Zealand

Alvotech has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, and in Australia and New Zealand.

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