The U.S. Food and Drug Administration (FDA) has approved vonoprazan tablets 10 mg and 20 mg (Voquezna, Phathom Pharmaceuticals) for the cure and maintenance of healing of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief from associated heartburn, the company announced. Vonoprazan, an oral potassium-competitive acid …
Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The original product is available in intravenous and subcutaneous formulations. The FDA has approved Wezlana (ustekinumab-auub), making it the first approval for blockbuster biosimilar drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability …
The U.S. Food and Drug Administration (FDA) approved Phathom Pharmaceuticals’ vonoprazan (Voquenza) on November 1, 2023 for the treatment of adults with erosive esophagitis (erosive GERD), a gastroesophageal reflux disease. The drug is expected to be commercially available by December 2023. The drug’s approval marks a critical moment for more than 20 million patients suffering …
The U.S. Food and Drug Administration (FDA) has approved secukinumab for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). This development, announced today, makes secukinumab the first and only interleukin (IL)-17A inhibitor approved by the FDA for the treatment of HS, which affects approximately 1% of the global population. It joins adalimumab, …
Pictured: A boy sitting in a wheelchair on a beach/iStock, ChiccoDodiFC The FDA on Thursday approved Santhera Pharmaceuticals’ new corticosteroid vamorolone, now marketed under the brand name Agamree, for the treatment of Duchenne muscular dystrophy. The announcement was made by Florida-based Catalyst Pharmaceuticals, which paid $90 million upfront in June 2023 and pledged up to …