significant side effects, and the treatment has achieved clinical and commercial success since it was first cleared by the FDA as a 510(k) device and sold in 2015. About Cytonics Corp: Cytonics, founded in 2006, is a private research and...
age-related macular degeneration (AMD), following the end of a voluntary recall. The U.S. Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level...
Yimmugo® in the U.S., following its Biologic License Application (BLA) approval by the U.S. Food and Drug Administration (FDA). Immunoglobulin therapies, such as Yimmugo®, are essential in managing primary immunodeficiencies (PID), which affect...
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or...
of CalciMedica. "We plan to move quickly towards initiating our Phase 3 trial in AP and are eager to engage with the FDA to discuss our trial plans once we have all the data from CARPO. We look forward to unlocking Auxora's potential to treat these...
in the late phase of preclinical development and plans to file an Investigational New Drug (IND) application with the FDA shortly to initiate treatment of advanced lung cancer patients. "Immorta Bio is a Scientific Longevity Company. In that regard...
BioArctic AB's partner Eisai announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly lecanemab-irmb (U.S. brand name: Leqembi)...
NV (‘Agomab’) announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AGMB-447, its inhaled, small molecule inhibitor of ALK5. Agomab is evaluating AGMB-447 as a potential treatment for Idiopathic...
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 drug application ("NDA") for...
a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to...
Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing agreement includes upfront, commercialization milestones, and sales milestones, with...
is anticipated to increase collection 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...
formulations of products to serve the needs of overlooked patients, announced that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an...
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,...
for Injection to wholesale partners this week. The Company is supported by a global network of development and FDA-approved cGMP-certified contract manufacturing partners. Eptifibatide for Injection had U.S. sales of approximately $8.3 million for...
Genmab A/S announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer...
and offer a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or...
and durability of this technology. The quality of this data and our rigorous test methods were validated with the full FDA IDE approval of the US study. The initiation of these studies is a critical step on the path to providing Hyalex technology...
ImmunityBio, Inc. an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with...
reduce the risk of post operative complications and improve outcomes following cardiothoracic surgery. RBT-1 has received FDA Breakthrough and Fast Track Designations. "Presenting at EACTS enables Renibus to share our promising RBT-1 results with...
