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Berotralstat

[L41960] In December 2025, the FDA expanded Berotralstat pediatric use with approval of an oral pellet formulation for prophylaxis in children with HAE aged 2 and older.[L54793,L54798]

Fidanacogene elaparvovec

[L46691] Hemophilia B is a rare X-linked genetic disorder characterized by abnormal coagulation due to dysfunctional coagulation factor IX with a male incidence estimated to be 1 in 30,000 male births … positive results demonstrated in the open-label, single-arm Phase 3 BENEGENE-2 study, where the annualized bleeding rate (ABR) was observed to be 1.3 for the 12 months from week 12 to month 15 compared to an

Lesopitron

Lesopitron is an anxiolytic with pre- and post-synaptic 5-HT1A agonist activity, which is under development by Esteve.

D-Methionine

Demecarium

Demecarium is an indirect-acting parasympathomimetic agent that is used to treat glaucoma. It is a cholinesterase inhibitor or an anticholinesterase.

Atidarsagene autotemcel

[L45191] Libmeldy was granted orphan designation by the EMA in April 2007, and was issued a marketing authorization in the EU in December 2020 for the treatment of certain manifestations of metachromatic

Elasomeran

[L28026] On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine. … For the 2024-2025 season, an updated formulation was approved for use in Canada and the US to target the Omicron KP.2 subvariant.[L51404,L40074]

Froniglutide

Glymera is under investigation in clinical trial NCT01658501 (Phase 2b Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study to Assess the PD Response and Safety of

TrenibotulinumtoxinE

[L64095,L64118] It is given as an intramuscular injection into the corrugator and procerus muscles, is intended for occasional use, and its potency units are not interchangeable with those of other botulinum

Candida albicans

Candida albicans is a fungus which can provoke allergic reactions. Candida albicans is used in allergenic testing.