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…
In a significant advancement for metastatic colorectal cancer (mCRC) patients with BRAF V600E mutations, Pfizer’s targeted therapy Braftovi® (encorafenib) has demonstrated remarkable efficacy in combination with cetuximab and chemotherapy. Recent Phase 3 BREAKWATER trial results…
Highlighted by Hong Kong DengYue Medicine What is Ensacove Ensartinib? Ensacove Ensartinib (X-396) is an advanced second-generation ALK tyrosine kinase inhibitor (TKI) designed to treat patients with ALK-positive non-small cell lung cancer (NSCLC). Developed to…
The U.S. Food and Drug Administration (FDA) has approved Crenessity™ (crinecerfont) as an adjunctive treatment to glucocorticoid therapy for adults and children aged four years and older with classic congenital adrenal hyperplasia (CAH) due to…
In a significant advancement for hemophilia care, the U.S. Food and Drug Administration (FDA) has approved Alhemo® (concizumab-mtci) as a once-daily prophylactic treatment for adults and children aged 12 years and older with hemophilia A…
