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 … Read more
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 … Read more
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 … Read more
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 … Read more
Pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi, Orasis Pharmaceuticals) has received FDA approval for the treatment of presbyopia in adults. Presbyopia is the loss of the ability to focus on nearby objects and is caused by the natural aging process. A press release from Orasis states that 128 million people in the United States are affected … Read more