FDA

The product is the first FDA-approved ophthalmic clobetasol propionate drug to hit the market, and is the first steroid to enter the ophthalmic space in more than 15 years, according to yesterday’s announcement.

Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.

The companies stated that their experimental drug against high blood pressure was shown to work when used in combination with the standard of care in a phase 2 trial.

Novo Nordisk

Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the US and EU in 2024. The detailed results from FLOW will be presented at a scientific conference in 2024.

Neither UnitedHealth nor the hackers involved have commented on the alleged ransom payment, but a cryptocurrency tracing firm partially corroborated the claim on Monday.

Walgreens

The pharmacy chain is instead looking for ways to drive “the most value” for the business, CEO Timothy Wentworth said at a conference on Monday.
Bloomberg News reported in January that Walgreens was exploring a sale of the unit.

Johnson & Johnson

Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.

The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.

The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease —amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving.

The company stated that it acquired the exclusive marketing rights for Europe for a new drug that is under regulatory review to treat a rare, potentially fatal heart disease for up to $310 million upfront.