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MyoPax Receives FDA Orphan Drug Designation for its Innovative Regenerative Cell Therapy for Exstrophy-Epispadias Complex
MyoPax aims to repair the congenital muscle defect associated with EEC using its cutting-edge highly regenerative muscle stem cell product
NIH-funded study explains link to increased cardiovascular risks for people with obstructive sleep apnea
Reduction in blood oxygen levels, largely attributed to blocked airways, emerges as a leading factor.
Beckman Coulter gets FDA nod for DxC 500 AU Chemistry Analyzer
Designed for small-to-medium-sized laboratories, DxC 500 AU is intended to improve laboratory workflows and support critical clinical decisions using standardised assays and reagents
EC approves Boehringer Ingelheim and Lilly’s Jardiance for CKD treatment
The EC’s approval is based on results from the EMPA-KIDNEY trial in which Jardiance reduced the relative risk of kidney disease progression or cardiovascular death by 28% versus placebo in people with CKD
Tarsus’ Xdemvy secures FDA approval for Demodex blepharitis treatment
The FDA’s approval was based on the findings of Saturn-1 and Saturn-2 trials in which XDEMVY showed considerable improvement in eyelids by day 43, with some patients seeing improvement as early as two weeks
Johnson & Johnson rolls out share exchange offer for Kenvue spin-off
According to the conditions of the exchange offer, Johnson & Johnson’s shareholders can trade all, some, or none of their shares of the company’s common stock for shares of Kenvue common stock
Quince Therapeutics agrees to buy EryDel and Phase 3 EryDex asset
Upon conclusion of the deal, Quince will fund the EryDex through the Phase 3 clinical trial under special protocol assessment (SPA) with the FDA for an anticipated NDA submission
Gilead’s lenacapavir shows positive results in Phase 2/3 trial of HIV patients
The study used five validated scoring tools that assessed health-related quality of life components, in which participants reported favourable scores at Week 52 and consistent results throughout the study
R21/Matrix-M Malaria Vaccine Leveraging Novavax’s Adjuvant Technology Gains Additional Authorization
The authorizations are based on Phase 2b trial results published in The Lancet Infectious Diseases, as well as confirmatory Phase 3 results that are anticipated for future publication
Verrica secures FDA approval for Ycanth topical solution to treat molluscum
Ycanth is a drug-device combination that contains a formulation of cantharidin (0.7%w/v) delivered through a single-use applicator, for precise topical dosing and targeted administration, administered by a healthcare professional, to treat molluscum