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.
New Market - January 12, 2026
Novo Nordisk’s Wegovy pill now broadly available across America
Wegovy pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off.
Biotech Business - January 2, 2026
Alvotech announces European launch of first-in-market biosimilar to Simponi
Alvotech has announced that launches are underway in Europe for Gobivaz (golimumab), Alvotech’s biosimilar to Simponi (golimumab), also known as AVT05 (prefilled syringe and autoinjector).
Biotech Business - December 9, 2025
Leqembi included in China’s commercial insurance innovative drug list
BioArctic’s partner Eisai has announced that Leqembi (lecanemab), has been included in the “Commercial Insurance Innovative Drug List”, recently introduced by the National Healthcare Security Administration (NHSA) of China.
