outcomes, are significant and meaningful from the perspective of the patient community. Currently, there is no U.S. FDA-approved therapy for the treatment of MPS IIIB, and disease management consists of limited palliative care. We are eager to see...
a clinical-stage biotechnology company, and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted. Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally...
pulmonary fibrosis (Bersiporocin), which has received both orphan drug designation and Fast Track status from the US FDA. About Daewoong Therapeutics: Daewoong Therapeutics Inc., is a subsidiary of Daewoong Group located in South Korea. The company...
Viatris Inc. a global healthcare company, announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric...
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...
Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...
This GMP license was the first step in the Company’s current foreign drug manufacturing site registration with the US FDA. In 2023, MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm’s reach to medical patients in Canada via Canna...
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis...
BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification. About BD: BD is one of the largest global medical technology companies...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. About Avenacy: Avenacy is a U.S.-based specialty pharmaceutical company focused on...
Injection, and Ketamine Injection. "Butorphic's launch reinforces our position among the animal health leaders in U.S. FDA ANADA approvals over the past several years, which is a testament to our team’s dedication to delivering high-quality,...
Areata Foundation (NAAF). "NAAF is thrilled to see expanded choices and increased opportunities for individuals to find an FDA-approved treatment to address hair loss caused by this autoimmune disease." LEQSELVI may cause serious side effects...
ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol® medicinal products for dry eye disease – Miebo® and Vevye® – are on the market in the United States revolutionizing...
(denosumab-bnht) and Bomyntra® (denosumab-bnht) - in the United States. These denosumab biosimilars are approved by the FDA for all indications of the reference products, Prolia® (denosumab) and Xgeva® (denosumab), respectively. Conexxence is...
a dispersed network of independent distributors across the United States. About VersaWrap® Hydrogel Sheet: VersaWrap is an FDA-cleared medical device implant (not tissue) comprising hyaluronic acid (HA) and alginate that provides a gelatinous...
Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also known as...
patients,” said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. “Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to...
from sample to result. "Traceability plays an important role in the security and integrity of pharmaceutical data, and the FDA considers the absence of records to be highly significant when data discrepancies are observed," said James Hallam, Vice...
estimated 130,180 deaths annually in the United States alone.1 In the last 10 to 15 years, accelerated clinical trials and FDA approvals of targeted therapies for non-small cell lung carcinoma have been possible in part due to advances in molecular...
models continue to support the pharmaceutical and biotechnology industry’s shift away from animal models as recognized by FDA Modernization Act 2.0 which allows drug developers to submit non-animal data to demonstrate safety and efficacy of...
