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Optune Lua® by Novocure Receives CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer

Novocure announced that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have...

Shorla Oncology Announces the Launch of Dedicated Sales Force and Market Access Teams as Part of Expansion of Its U.S. Commercial Footprint

Shorla Oncology a U.S.-Ireland specialty pharmaceutical company, announced the launch of a dedicated sales force and market access teams and the commercial availability of IMKELDI, the first oral liquid form of imatinib to treat certain forms of...

Dr. Scott Grady Makes Thyroid RFA More Accessible in Oregon

Dr. Scott Grady, an endocrinologist at Portland Diabetes & Endocrinology Center (PDEC), is making Thyroid Radiofrequency Ablation (RFA) more accessible to Oregon patients seeking a non-surgical alternative for benign thyroid nodules. Since 2022,...

Next Generation Gene Therapeutics (NGGT) announces the publication of early clinical trial results for NGGT001, a treatment for Bietti's Crystalline Dystrophy (BCD)

NGGT Inc., a clinical-stage biotechnology company pioneering the next wave of gene therapy innovation for genetic rare diseases, today announced the publication in the journal JAMA Ophthalmology of the results from a dose-escalation study in...

Pilatus Biosciences Inc. earns FDA Orphan Drug Designation for PLT012, targeting liver and intrahepatic bile duct cancer

Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November...

Biolexis Therapeutics reports positive outcomes for BLX-7006 in an expanded Diet-Induced Obesity (DIO) model study

Biolexis Therapeutics, a leading metabolic drug discovery company focused on improving the lives of patients with chronic metabolic conditions, including obesity, diabetes, and related diseases, announced the successful completion of an expanded...

Children’s Hospital Los Angeles completes its 100th retinal gene therapy procedure, advancing pediatric vision care.

His newly treated patients might show significant improvements on their eye chart tests, but Aaron Nagiel, MD, PhD, will tell you that the truest signs of visual progress come through the texts he receives from parents days, weeks, and months...

Aadi Bioscience reports Q3 2024 financial results and updates on corporate progress

Aadi Bioscience, Inc. announced financial results for the third quarter ended September 30, 2024, and provided recent corporate progress. "The third quarter saw strong sales growth for FYARRO, backed by continued account momentum, increased demand...

ARTHEx Biotech doses first patient in Phase I-IIa ArthemiR™ trial for Myotonic Dystrophy Type 1

ARTHEx Biotech S.L., a clinical-stage biotechnology company focused on developing innovative medicines through the modulation of gene expression, announced that the first participant has been dosed in the Randomized Placebo Controlled Double Blind...

Citius Pharmaceuticals' LYMPHIR™ wins FDA approval for relapsed/refractory cutaneous T-cell lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...

Teva and Sanofi Announce Accelerated Anti-TL1A Phase 2b Program for Inflammatory Bowel Disease

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Sanofi announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal...

Indivior Publishes New Data Comparing Effectiveness of Intranasal Nalmefene (OPVEE 2.7mg) and IN Naloxone (4mg) in Synthetic Opioid Overdose Model

Indivior PLC announced the publication of a modeling study in Frontiers in Psychiatry that predicts OPVEE (nalmefene) nasal spray (2.7 mg nalmefene, equivalent to 3 mg of nalmefene hydrochloride) resulted in larger reductions in the incidence of...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection,...

Onconic Therapeutics gets MFDS nod for JAQBO, a fresh remedy for Gastroesophageal Reflux Disease

Onconic Therapeutics, a leading biotechnology company in Korea, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in...

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