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Lumacaftor

Lumacaftor is a drug used in combination with [DB08820] as the fixed dose combination product Orkambi for the management of Cystic Fibrosis (CF) in patients aged 6 years and older. … [FDA Label] This data has been heavily scrutinized, however, with clinical trials showing only modest improvements despite a hefty yearly cost of $259,000 for Orkambi.

Sodium borate

Zavegepant

[A258190,A258195] In March 2023, the FDA approved the use of zavegepant nasal spray for the acute treatment of migraine with or without aura in adults. … Zavegepant (BHV-3500) is a calcitonin gene-related peptide (CGRP) receptor antagonist.

Bordetella pertussis fimbriae 2/3 antigen

Bordetella pertussis fimbriae 2/3 antigen is a vaccine for the prophylaxis of the disease caused by Bordetella pertussis which is a a Gram-negative coccobacillus that expresses two serologically distinct

Florbetaben F-18

Florbetaben is a fluorine-18 (18F)-labeled stilbene derivative used for Positron Emission Tomography (PET) imaging of the brain. … This radioactive diagnostic drug is used for the non-invasive detection of the density of beta-amyloid plaques in the brain of adult patients with cognitive impairment.[A18514, L53703]

Rifamycin

[L4800] This drug was also sent for review to the EMA in 2015 by Dr. Falk Pharma Gmbh and it was granted a waiver for the tested conditions.[L4801] … Product which allowed it to have a status a priority review.

Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen

Neisseria meningitidis serogroup B recombinant lp2086 a05 protein variant antigen is a sterile vaccine for intramuscular injection indicated for the active immunization to prevent invasive disease caused … A and one from subfamily B (A05 and B01, respectively).

Arbutamine

diagnosing the presence or absence of coronary artery disease in patients who cannot exercise adequately . … Arbutamine, administered through a closed-loop, computer-controlled drug-delivery system, is indicated to elicit acute cardiovascular responses, similar to those produced by exercise, in order to aid in

Bevacizumab

There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. … [L45793,L43130] For over a decade, bevacizumab was also used off-label by intravitreal injection to treat neovascular (wet) age-related macular degeneration and other retinal conditions, repackaged from

Infigratinib

cholangiocarcinoma in adults with a fibroblast growth factor receptor 2 (FGFR2) fusion or another rearrangement as detected by an FDA-approved test. … Infigratinib is a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor.