Kolon Eases Financial Burden from Invossa Development as Legal Hurdles Gradually Clear

Kolon Group reduces financial risk from Invossa gene therapy as legal challenges ease, boosting corporate value with the drug’s U.S. market potential nearing $7.5 billion.

The FDA’s Lax Generic Drug Rules Can Put Patients’ Lives at Risk – The USA Potato

Alteogen Posts 900% Surge in Q3 Revenue as ALT-B4 Commercialization Accelerates

Alteogen Co. posted a 900% jump in Q3 revenue, driven by the commercialization of its ALT-B4 platform and milestone payments from FDA-approved Keytruda SC, marking a major turnaround in profitability and global expansion momentum.

Celltrion Secures Additional FDA Approval for Yuflyma 10mg Formulation in US

Celltrion has received additional FDA approval for its Yuflyma 10mg pre-filled syringe, expanding its US high-concentration biosimilar lineup for pediatric autoimmune treatment.

Celltrion Secures Additional Pediatric Indications for Yuflyma in US

Celltrion has received FDA approval for additional pediatric indications of Yuflyma in the US, targeting pediatric uveitis and hidradenitis suppurativa, and aims to expand its market presence as exclusivity for the original drug expires.

Celltrion Receives US FDA Approval for Ophthalmic Drug ‘Eylea’

Celltrion has secured US FDA approval for its Eylea biosimilar, Eydenzelt, expanding its US portfolio, though commercial launch is delayed amid ongoing patent litigation with Regeneron.

Novo Nordisk Shares Surge 5% as Wegovy Wins FDA Approval for Fatty Liver Disease Treatment

Shares of Novo Nordisk jumped nearly 5% in pre-market trading after its obesity drug Wegovy secured FDA approval as a treatment for fatty liver disease (MASH).