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Lerodalcibep

[L54738] Approved by the FDA on December 15, 2025, lerodalcibep is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia … [L54738] PCSK9 is a protein that binds to and promotes the degradation of low-density lipoprotein receptors (LDLRs), which are expressed on hepatocytes regulates circulating LDL levels.

Primidone

[L11112] Primidone was developed by J Yule Bogue and H C Carrington in 1949.[A189522] Primidone was granted FDA Approval on 8 March 1954.[L11112] … Primidone is an anticonvulsant used to treat essential tremor as well as grand mal, psychomotor, and focal epileptic seizures.

Bufexamac

The use of bufexamac has been discontinued in Canada and the United States, which may be due to undetermined clinical efficacy and a high prevalence of contact sensitization [A32822]. … It has also been used in suppositories in combination with local anaesthetics indicated for haemorrhoids.

Alpelisib

[L6652] In April 2022, the FDA granted the use of alpelisib in the treatment of PIK3CA-Related Overgrowth Spectrum (PROS) in adults and children who require systemic therapy.[L41384] … Alpelisib was granted FDA approval on 24 May 2019.

Elivaldogene autotemcel

[L40298] In September 2022, Skysona was approved by the FDA.[L43247] … It was approved by the European Commission in July 2021 under the market name Skysona, and was later withdrawn in November 2021 at the request of the marketing-authorization holder.

Agomelatine

Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. … In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis. The development for the US market was discontinued in October 2011.

Bentiromide

Bentiromide is currently not available in the U.S. or Canada. … Bentiromide is a dipeptide that is used in the bentiromide test, which is a screening test for evaluating pancreatic exocrine function and monitoring the adequacy of supplemental pancreatic therapy.

Zinc ascorbate

Linaclotide

Linaclotide was first approved by the FDA on August 30, 2012.[A260271] It gained EMA and Health Canada approval on November 26, 2012 [L47216] and December 3, 2013,[L47221] respectively. … Linaclotide is a synthetic 14-amino acid cyclic peptide [A260271] and first-in-class guanylate cyclase-C (G-CC) agonist.

Bifidobacterium longum infantis