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Talniflumate

Talniflumate has been approved for approximately 20 years in Argentina other countries (excluding the United States, Europe, and Japan) [L1405]. … In addition, it is used in inflammatory conditions such as rheumatoid arthritis.

AT2220

AT2220 has been shown to increase GAA activity in cell lines derived from Pompe patients and in transfected cells expressing misfolded forms of GAA. … AT2220 is an experimental, oral therapy for the treatment of Pompe disease and belongs to a class of molecules known as pharmacological chaperones.

Dostarlimab

A prospective phase II study in patients with mismatch repair-deficient locally advanced rectal cancer resulted in all twelve patients exhibiting a complete clinical response.[A248905] … [L33340] This indication was granted full FDA approval on February 10, 2023.[L45161] Dostarlimab-gxly was granted second accelerated approval for the treatment of solid tumours in the same month.

Vamorolone

[L48671,L48676] In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age.[L49505] … [L48676] Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age.

Imgatuzumab

Imgatuzumab is under investigation in clinical trial NCT01326000 (A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With

Gefapixant

It received approval in both Japan and Switzerland in 2022 for the treatment of adult patients with RCC and UCC, and received subsequent approval in the EU in September 2023 for the same indications. … [L48596,L48591] It is the first therapy to be approved for the treatment of RCC or UCC in the EU.[L48601]

Pegilodecakin

Pegilodecakin is under investigation in clinical trial NCT03382912 (Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small

Celecoxib

[A181544] It is used to manage symptoms of various types of arthritis pain and in familial adenomatous polyposis (FAP) to reduce precancerous polyps in the colon. … [A181532] It is marketed by Pfizer under the brand name Celebrex, and was initially granted FDA approval in 1998.

Haemagglutinin-strain B (Victoria-like)

Zoliflodacin

[A275268] Zoliflodacin is a first-in-class spiropyrimidinetrione antibiotic designed to address this need by inhibiting bacterial type II topoisomerases (DNA gyrase and topoisomerase IV), thereby blocking … FDA in December 2025, following Fast Track, Qualified Infectious Disease Product, and Priority Review designations.[L54743,L54803]