In a landmark advancement for nuclear cardiology, GE HealthCare has launched Flyrcado™ (flurpiridaz F 18), the first FDA-approved unit-dose positron emission tomography (PET) myocardial perfusion imaging (MPI) agent for detecting coronary artery disease (CAD). Approved in September 2024 and commercially available in select…
The U.S. Food and Drug Administration (FDA) has approved Itovebi™ (inavolisib), developed by Genentech, a member of the Roche Group, in combination with palbociclib and fulvestrant, for the treatment of adults with endocrine-resistant. PIK3CA-mutated, hormone…
In October 2024, the U.S. Food and Drug Administration (FDA) approved Orlynvah™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women with limited or no alternative oral antibacterial…
In November 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Ziihera® (zanidatamab-hrii), marking a significant advancement in the treatment of previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer…
FDA Approval Attruby Market Impact Attruby™ (acoramidis), developed by BridgeBio Pharma, received FDA approval in November 2024 as the first near-complete (≥90%) transthyretin (TTR) stabilizer for transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and often fatal…
Bizengri represents a paradigm shift in treating NRG1+ cancers, offering hope for patients with historically poor prognoses. As precision medicine advances, RNA-based testing for NRG1 fusions will be crucial to identify eligible candidates. With ongoing research, Bizengri may soon…
April 18, 2025 — Phoenix, AZ — In a significant advancement for Alzheimer’s disease treatment, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla™ (donanemab-azbt) on July 2, 2024. This monoclonal antibody therapy…
In a significant advancement for oncology therapeutics, the U.S. Food and Drug Administration (FDA) approved Unloxcyt™ (cosibelimab-ipdl) on December 13, 2024, for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma…
Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a leader in rare disease therapeutics, has announced a strategic out-licensing agreement with Esteve Pharmaceuticals, S.A., granting the latter exclusive rights to commercialize Increlex® (mecasermin injection) outside the U.S. for up to…
GlaxoSmithKline’s immunotherapy drug, Jemperli (dostarlimab-gxly), is making significant strides in oncology, particularly in treating endometrial and rectal cancers. Recent FDA approvals and clinical trial outcomes have positioned it as a promising option for patients with…
The U.S. Food and Drug Administration (FDA) has expanded its approval of Sobi’s (Swedish Orphan Biovitrum AB) Kineret® (anakinra) for the treatment of patients with pneumonia caused by COVID-19, especially those at risk of progression…
April 17, 2025 — Lupus nephritis (LN) is a serious autoimmune disease that has long lacked efficient and safe treatment options. However, with the approval of Lupkynis® (voclosporin), developed by Aurinia Pharmaceuticals, this landscape is…
