- Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers
April 1, 2025 -- A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness in patients with metastatic gastrointestinal cancers, according to...
- Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 31, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and...
- AZD0780, a Novel Oral PCSK9 Inhibitor, Demonstrated Significant LDL Cholesterol (LDL-C) Reduction in PURSUIT Phase IIb Trial
31 March 2025 -- Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin...
- Lilly's Lepodisiran Reduced Levels of Genetically Inherited Heart Disease Risk Factor, Lipoprotein(a), by Nearly 94% from Baseline at the Highest Tested Dose in Adults with Elevated Levels
INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive Phase 2 results for lepodisiran, an investigational small interfering RNA (siRNA) therapy designed to lower the production of lipoprotein(a)...
- Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) Keytruda® (pembrolizumab) in Pivotal 3475A-D77 Trial
RAHWAY, N.J.--(BUSINESS WIRE) March 27, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous...
- Chlamydia Vaccine Candidate Granted Fast Track Designation by the US FDA
Paris, March 26, 2025. The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to...
- Palatin’s Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency
CRANBURY, N.J., March 25, 2025 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system...
- The United Laboratories and Novo Nordisk Announce Exclusive License Agreement for UBT251, a GLP-1/GIP/Glucagon Triple Receptor Agonist
Guangdong, China and Bagsværd, Denmark, 24 March 2025 –The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United...
- NIH Researchers Develop Eye Drops That Slow Vision Loss in Animals
Researchers at the National Institutes of Health (NIH) have developed eye drops that extend vision in animal models of a group of inherited diseases that lead to progressive vision loss in humans, known as retinitis pigmentosa. The eye drops contain...
- Omeros Corporation Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial Program
SEATTLE--(BUSINESS WIRE)--Mar. 21, 2025-- Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal...
- New Data on Investigational Therapy Doxecitine and Doxribtimine for Thymidine Kinase 2 Deficiency Presented at Muscular Dystrophy Association (MDA) 2025 Conference
Brussels (Belgium) 19 March 2025 – UCB, a global biopharmaceutical company, today announced positive data from studies involving its investigational pyrimidine nucleoside therapy, doxecitine (dC) and doxribtimine (dT), in people living with...
- Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies
NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported topline results from its Phase 3 study of...
- Henlius Receives Orphan-Drug Designation for HLX22 (Innovative anti-HER2 mAb) in the U.S. for Gastric Cancer
Shanghai, China, March 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for...
- Azer-cel Granted FDA Fast Track Designation in Blood Cancer DLBCL
SYDNEY, Australia, 19 March 2025: Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, is pleased to announce that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its allogeneic CAR T-cell therapy...
- FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Ramat Gan, Israel, March 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases...
- Sarepta Therapeutics Shares Safety Update on Elevidys
CAMBRIDGE, Mass., March 18, 2025 -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following safety update related to Elevidys (delandistrogene moxeparvovec-rokl), the only approved...
- Signal12 Achieves FDA Alignment, Accelerating Pro-ocular™ Towards Phase 3 Clinical Trials for Ocular Graft-versus-Host Disease
BOSTON, March 18, 2025 /PRNewswire/ -- Signal12, Inc. (Signal12), a clinical-stage ophthalmic pharmaceutical company focused on first-of-a-kind patented technologies that enable existing drugs to act through unique neural pathways, today announced...
- Nipocalimab, the First and Only Investigational Treatment to be Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Adults with Moderate-to-Severe Sjögren’s Disease, has now Received Fast Track Designation
SPRING HOUSE, Pa., (March 18, 2025) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients...
- vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes
HIGH POINT, N.C., March 17, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being...
- BioArctic Receives Orphan Drug Designation for Exidavnemab the US
Stockholm, March 17, 2025 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple...
- Eneboparatide Met Primary Endpoint of Normalising Serum Calcium in Adults with Hypoparathyroidism at 24 weeks in CALYPSO Phase III Trial
March 17, 2025 -- High-level results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance in adults with...
- Investigational Rinatabart Sesutecan (Rina-S®) Continues to Show Encouraging Antitumor Activity in Patients with Advanced Ovarian Cancer
COPENHAGEN, Denmark; March 17, 2025 -- Genmab A/S (Nasdaq: GMAB) announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted...
- NIH-Funded Study Identifies Potential New Stroke Treatment
March 17, 2025 -- In a preclinical study, rodents treated with uric acid showed improved long-term outcomes after acute ischemic stroke. The findings suggest that the treatment may work as an add-on therapy to standard stroke treatments in humans...
- Surgery in Kids with Mild Sleep-Disordered Breathing Tied to Fewer Doctor Visits, Meds
March 17, 2025 -- Surgical removal of enlarged tonsils and adenoids in children with mild sleep-disordered breathing (SDB) appears to significantly reduce the frequency of medical office visits and prescription medicine use in this group, according...
- Nurix Announces U.S. FDA Orphan Drug Designation Granted to Bexobrutideg (NX-5948) for the Treatment of Waldenström Macroglobulinemia
SAN FRANCISCO, March 17, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today...