Takeda Pharmaceutical has reached a significant milestone in the development of oveporexton (TAK-861), with the US Food and Drug Administration officially accepting and granting Priority Review status to the investigational…
The U.S. Food and Drug Administration has agreed to review Otsuka Pharmaceutical’s application for centanafadine, a new extended‑release therapy under investigation for attention‑deficit hyperactivity disorder (ADHD). The agency has granted…
Vera Therapeutics announced a major milestone in drug development on January 7, 2026, when the U.S. Food and Drug Administration granted Priority Review to the Biologics License Application (BLA) for…
The U.S. Food and Drug Administration (FDA) has approved Yartemlea (narsoplimab‑wuug), marking the first authorized therapy for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA) in adults and children aged 2…
As reported by Forbes, the U.S. Food and Drug Administration has granted approval to Flow Neuroscience for the first prescription brain stimulation device designed for home use in treating major…
As reported on PharmaBiz, Amneal Pharmaceuticals, in collaboration with mAbxience, has received U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars: Boncresa (referencing Prolia) and Oziltus (referencing Xgeva).…
A rare and life-threatening kidney disease affecting young adults and children finally has an effective and approved therapy due to the pioneering and leadership of researchers at the Iowa University’s…
Light chain amyloidosis (AL) is a progressive and rare disease whereby abnormal plasma cells found in the blood and urine over-produce light chain proteins. These proteins misfold into amyloid fibrils…
Arrowhead Pharmaceuticals has secured its first U.S. approval with Redemplo, an RNA interference therapy cleared by the FDA for adults with familial chylomicronemia syndrome (FCS). Used alongside dietary management, as…
Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Utah, has announced that its investigational drug, ofirnoflast (HT-6184), has received Orphan Drug Designation (ODD) from the U.S. Food and Drug…
Xspray Pharma, the developer of the drug dasatinib, was recently issued a Complete Response Letter (CRL) by the FDA while waiting for corrective actions, according to Cancer Network. Based on…
Portal Therapeutics, in partnership with GondolaBio, has achieved a milestone with the FDA granting orphan drug and fast track status to its oral therapy candidate, PORT-77. This investigational drug, according…
In a major advance for patients with the rare eye disease keratoconus, Glaukos has secured U.S. Food and Drug Administration (FDA) approval for Epioxa, an incision-free corneal cross-linking therapy. As…
On October 2, 2025, Novartis announced a significant milestone in the treatment of chronic spontaneous urticaria (CSU): the US Food and Drug Administration (FDA) approved Rhapsido® (remibrutinib) as the first…
This past September, the urothelial cancer field witnessed several groundbreaking developments, offering new hope for patients and fresh strategies for clinicians. As reported by OncLive.com, from regulatory milestones to innovative…
After years of setbacks and uncertainty, Stealth BioTherapeutics has achieved a historic breakthrough with FDA approval of Forzinity (elamipretide), the first treatment for Barth syndrome, an ultrarare, life-limiting genetic disorder.…
Lexeo Therapeutics announced a significant regulatory development this week: the U.S. Food and Drug Administration (FDA) is open to a faster approval pathway for the company’s promising gene therapy, LX2006,…
The U.S. Food and Drug Administration (FDA) has granted an expanded indication for Vonvendi, Takeda’s recombinant von Willebrand factor (rVWF) therapy, marking a significant advancement in the management of rare…
The U.S. Food and Drug Administration (FDA) is reviewing the first medication specifically developed for Barth syndrome, a rare and life-threatening genetic disorder. As reported by STAT, this medication could…
PTC Therapeutics has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of SEPHIENCE™ (sepiapterin), marking the first and only therapy approved for broad treatment of…
June 2025 marked a month of significant progress in cancer care, as the FDA approved several new therapies and treatment combinations across a range of cancer types. As reported by…
Fujifilm Corporation’s investigational therapy FF-10832 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of biliary tract cancer, according to a recent announcement…
Global biotechnology leader CSL recently announced the FDA’s approval of ANDEMBRY, a monthly subcutaneous (under-the-skin) self-injection. The treatment was recently FDA approved for the prevention of hereditary angioedema (HAE) attacks…
On Monday, February 12 the Food and Drug Administration approved Eohilia, a budesonide corticosteroid oral suspension for patients aged 11 years and older with eosinophilic esophagitis (EoE) patients in the…
A recent article on Yahoo Finance, reports that Alnylam Pharmaceutical Inc.’s RNAi therapeutic, Amvuttra, has been approved by the FDA to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. Amvuttra (Vutrisiran)…
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