(The Hill) The Food and Drug Administration (FDA) approved Eli Lilly’s blockbuster diabetes drug for weight loss management on Wednesday, giving patients another tool and opening the door to potentially using much wider. Formal FDA approval means tirzepatide could be covered by most insurance plans, making it more affordable for millions of patients and likely …
The Food and Drug Administration on Wednesday has approved Zepbound, a new weight loss drug from drugmaker Eli Lilly that in clinical trials has been shown to help people lose up to 52 pounds in 16 months. Related to Zep is the latest entrant in the field of powerful new drugs that already includes Novo …
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 …
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 …
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) 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, …
The FDA approved the Prior Approval Supplement (PAS) for reformulation of vonoprazan tablets for vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets (Voquenza Triple Pak; Phathom Pharmaceuticals) as well as vonoprazan tablets and amoxicillin capsules (Voquenza Dual Pak; Phathom Pharmaceuticals) for the treatment of Helicobacter pylori (H. pylori) infection in adult patients. The treatment regimens contain …
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 …
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 …
The FDA has approved tenapanor (Xphozah; Ardelyx, Inc.), making it the first and only phosphate absorption inhibitor approved to reduce serum phosphorus in adults with chronic kidney disease (CKD) who are on dialysis as adjunctive therapy in patients who either do not respond to phosphate binders or who are intolerant to any dose of phosphate …