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FDA Clears Rika Plasma Donation System's Individualized Nomogram

volume without increasing collection time. The clinical trial to support the recent FDA clearance showed an average 10% increase in the volume of plasma collected per donation with an average collection time of less than 35 minutes.2 The Terumo BCT...

ONFAB, High Potent Containment Provider, Expands into USA Market

Ingredients (HPAPIs). ONFAB prides itself on high standards of customer service and manufacturing and is ISO 9001 accredited. the internationally recognized standard for an organization's internal quality management. For more information please...

BioLineRx Unveils Poster Presentation on Economic Model Data for APHEXDA® in CD34+ Hematopoietic Stem Cell Mobilization

of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more...

Regulus Therapeutics Progresses to Cohort 4 in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

after review of all available safety data, the Company initiated screening of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the fourth cohort will receive an open label fixed dose of 300...

Adcentrx Therapeutics: China NMPA Clears IND for ADRX-0706, a Novel Nectin-4 ADC in Advanced Solid Tumor Treatment

Drug (IND) application for ADRX-0706 which enables the company to include China-based clinical centers in the ongoing Phase 1a/1b study for the treatment of select advanced solid tumors. ADRX-0706 is an ADC comprised of a novel fully human IgG1...

enGene to Showcase Pivotal Phase 1/2 LEGEND Study Details of EG-70 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

non-muscle invasive bladder cancer (NMIBC), today announced an oral presentation. The presentation, "LEGEND: a Phase 1/2 study of EG-70 (detalimogene voraplasmid), a novel, non-viral intravesical gene therapy for patients with BCG-unresponsive...

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

a significant patient treatment milestone for the most prevalent bleeding disorder in the United States. VWD affects up to 1% of the U.S. population, including many who are undiagnosed. "The FDA orphan exclusivity is exciting news for Octapharma...

Aurora enhances Australian offerings with premium dried flower range

as they continue to expand their offerings under the Aurora brand. The dried flower products are available now in four 10g formats including: "This expanded offering aims to serve patients with more choice, novel cultivars and expertly grown...

TIVDAK® Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer

or metastatic cervical cancer with disease progression on or after chemotherapy. This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval. TIVDAK is the first antibody-drug conjugate (ADC) with demonstrated...

Avenacy announces launch of Eptifibatide for Injection in the U.S.

syndrome (ACS) and percutaneous coronary intervention (PCI). Avenacy’s Eptifibatide for Injection is available as a 75 mg/100 mL single-dose vial. In line with Avenacy’s mission to champion patient safety and streamline patient care, Eptifibatide...

Medtronic, Heart-Valve-Surgery.Com launch 'Aortic Stenosis Patient Activation Platform

Cardiology at MetroHealth. Without treatment, up to 50% of patients will die 24 months after the onset of symptoms1. According to Dr. Kendra Grubb, Surgical Director of the Emory Structural Heart & Valve Center, approximately 40%† of patients with...

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

Livzon Pharmaceutical Group, the leading seller of PPIs in China for development and commercialization, in a deal value of $127.5 million for Greater China. Onconic Therapeutics is committed to enhancing gastrointestinal treatment and improving...

Nature Publication Highlights the Benefits of Tropis® Intradermal

to improve the performance and outcomes of medicines with its innovative delivery systems, announced the Nature publication1 of Gennova Biopharmaceutical’s Phase 2/3 clinical trial conducted to evaluate the safety and immunogenicity of its novel...

VETIGEL is now available through all major U.S. distributors of veterinary products and services

pre-filled syringe, easy-to-use, and requires no preparation or special storage conditions. Since the product's debut in 2021, veterinary surgeons across North America, Europe, and Asia have increasingly used VETIGEL as the fastest and most...

Factor Bioscience to Deliver Seven Presentations at the American Society of Gene & Cell Therapy

our results in these and other areas next month at the ASGCT Annual Meeting." About Factor Bioscience Founded in 2011, Factor Bioscience develops technologies for engineering cells to promote health and improve lives. Factor Bioscience is privately...

SOPHiA GENETICS Announces Syndicate Bio as First Liquid Biopsy Customer in Africa

Sloan Kettering Cancer Center (MSK), and Syndicate Bio to advance health equity on a global scale. There are roughly 1 million new cancer patients each year in Africa and currently, comprehensive genomic profiling and liquid biopsy testing options...

Hyalex Orthopaedics Reports Treatment of First Patients with Novel HYALEX® Knee Cartilage System

cartilage repair as compared to traditional orthopaedic materials. The ongoing clinical trials (NCT06368700 and NCT06344481) are evaluating the safety and technical performance of the HYALEX Knee Cartilage System in symptomatic patients who require...

ImmunityBio Announces FDA Approval of ANKTIVA®,

a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.” ANKTIVA, a first-in-class IL-15 agonist immunotherapy for NMIBC, received Breakthrough Therapy Designation and approval from the FDA based on the safety...

Renibus Therapeutics to Present RBT-1 at European Association for Cardio-Thoracic Surgery

focusing on the prevention and treatment of cardio, renal and metabolic diseases, announced an oral presentation on RBT-1 at the prestigious, RBT-1 (stannic protoporfin / iron sucrose) is a single dose, multi-organ, preconditioning agent that is...

Cellares Launches Cell Q, the World’s First Automated cGMP QC Workcell for Cell Therapies

our Cell Shuttle™ platform. This enables the Cellares IDMO to offer a real end-to-end solution for our customers, providing 10 times higher capacity and up to 50% lower batch price,” said Fabian Gerlinghaus, CEO of Cellares. “Our proprietary...