As reported on PharmaBiz, AstraZeneca’s phase III LATIFY trial has fallen short of its primary objective, with the combination of the ATR inhibitor ceralasertib and the PD‑L1 inhibitor Imfinzi (durvalumab)…
As reported by The Pharma Letter, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new indication for argenx’s Vyvgart (efgartigimod alfa), expanding the therapy’s use to…
As reported on Forbes, a class of drugs first introduced to combat HIV is now demonstrating unexpected promise for patients with rare genetic and mitochondrial disorders. Once designed to block…
As reported on FierceBioTech, Biohaven closed out the holiday period with disappointing news: its investigational Kv7.2/7.3 potassium‑channel modulator, BHV‑7000, did not demonstrate efficacy in a phase 2 clinical trial for…
As reported by NewsWise, new clinical study led by investigators at the University of North Carolina at Chapel Hill is offering rare hope for families affected by Hunter syndrome, a…
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 Science Daily, a recent clinical study suggests that a traditional Chinese herbal remedy may offer a unique advantage in treating major depressive disorder (MDD) while paving the…
CRISPR Therapeutics has announced encouraging early results for zugocaptagene geleucel (zugo-cel), its investigational allogeneic CAR T therapy targeting CD19, in both autoimmune diseases and hematologic malignancies. Autoimmune Disease Progress In…
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).…
As reported on Science Daily, a groundbreaking study suggests that customizing breast cancer screening based on individual risk factors may outperform the traditional one-size-fits-all approach of annual mammograms. The research,…
In a recent statement, the U.S. Food and Drug Administration (FDA) has authorized regular approval to rucaparib (Rubraca) for adults with metastatic castration-resistant prostate cancer (mCRPC) harboring deleterious BRCA mutations—either…
Incyte has announced encouraging top-line findings from its pivotal Phase III frontMIND trial, evaluating tafasitamab (marketed as Monjuvi/Minjuvi) in combination with lenalidomide and the standard R-CHOP regimen for newly diagnosed…
Editor's Note: The following study results were first published in Nephrology Dialysis Transplantation (December 16, 2025) and later shared in the Oxford Academic. The original study authors are Zinaida S.…
As reported on FiercePharma, Johnson & Johnson has secured a significant milestone in prostate cancer treatment with the FDA’s approval of Akeega for patients with BRCA2-mutated metastatic castration-sensitive prostate cancer…
As reported on PharmaBiz, GENESIS Pharma has announced an exclusive agreement with Otsuka Pharmaceutical Europe Ltd. (OPEL) to distribute and commercialize donidalorsen across 14 Central and Eastern European countries, including…
As reported on PharmaBiz, Renalys Pharma has reported encouraging topline data from its Phase III trial evaluating sparsentan (RE-021), an oral dual endothelin and angiotensin II receptor antagonist, in Japanese…
As reported on BioPharmaDive, the U.S. Food and Drug Administration (FDA) has granted early approval for a new frontline treatment option for HER2-positive metastatic breast cancer. The regimen combines AstraZeneca…
As featured on KFF News, Heidi DiLorenzo was preparing to welcome her second child, and her biggest concern wasn’t taking Zoloft. The Birmingham attorney had relied on the medication for…
As reported by Healio, the U.S. Food and Drug Administration (FDA) has officially qualified AIM-MASH AI Assist, marking a milestone as the first artificial intelligence tool cleared to support drug…
Sixteen years ago, Nate Appleman, a celebrated chef, faced every parent's worst nightmare when his two-year-old son, Oliver, fell ill. Oliver’s diagnosis was a complete shock. He was a healthy…
Lumos Labs has received FDA 510(k) approval for LumosityRx, a prescription version of its well-known Lumosity brain training platform. As reported by Fierce BioTech, The app is now authorized for…
In a recent statement, The U.S. Food and Drug Administration (FDA) has introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot, a groundbreaking initiative aimed at expanding access to digital health…
In a statement by the FDA, the U.S. Food and Drug Administration has authorized Waskyra (etuvetidigene autotemcel), the first gene therapy designed to treat Wiskott-Aldrich syndrome (WAS), a rare and…
As reported by MedicalXpress, Researchers have uncovered a surprising immune function in specialized intestinal cells that may reshape our understanding of gut health and autoimmune disorders. The study, published in…
As reported on BioPharmaDive, new clinical trial data presented at the American Society of Hematology (ASH) annual meeting suggests that an early treatment regimen combining Tecvayli (Johnson & Johnson’s bispecific…
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