follows the successful debut of limited quantities of Niagen IV and injections in select clinics earlier last month. U.S. FDA-registered 503B outsourcing facility, Wells Pharma of Houston, will compound and distribute pharmaceutical-grade Niagen,...
development and manufacturing as well as CDMO services. Viwit has three integrated product R&D centers, three cGMP US FDA inspected production facilities. By continuously improving the level, depth and scope of innovation, Viwit makes every effort...
City of Hope professor of breast surgery and lead investigator of the trial. "We hope this work will yield innovative, FDA-approved therapies to help patients complete their lifesaving treatments." The clinical trial entitled "High Cannabidiol...
HACCP and FSSC22000 for food-grade materials—while achieving certifications from global regulatory bodies including the FDA, MFDS, and PMDA. This commitment to quality enables Bloomage to serve diverse markets with confidence, continually driving...
of novel therapies for diseases involving mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting with the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) on October...
medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,500 hospitals and medical institutions across 50+...
Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is...
for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's...
kit, CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. The Company is advancing its Lung EpiCheck® test towards...
Therapeutics for the exclusive distribution of TARPEYO® (budesonide) delayed release capsules TARPEYO® (is the first FDA-approved treatment to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN).1 Primary...
non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions of exon 21 L858R mutations, as detected by an FDA-approved test. This new regimen shows superior progression-free survival versus the traditional standard of care. “Onco360...
healthy individuals and people living with ALS. Prosetin is an investigational new drug and has not been approved by the FDA.
*The Ibex suite includes solutions which are for Research Use Only (RUO) in the United States and not cleared by the FDA. Multiple solutions are CE marked (IVDD and IVDR) and registered with the UK Healthcare products Regulatory Agency (MHRA). For...
on the development of innovative therapies for autoimmune diseases, announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application for FTX-101, enabling the company to initiate its planned...
the potential to bring transformational benefits to patients, announced the United States Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor...
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in...
system approved with neffy® (epinephrine nasal spray), the first and only needle-free treatment approved by the U.S. FDA for the emergency treatment of patients with allergic reactions (Type I), including anaphylaxis. This marks the first...
from HERA (the European Health Emergency Preparedness and Response Authority) for the Company’s MVA-BN® vaccine, the only FDA and EMA-approved mpox vaccine. HERA will procure 175,420 doses of the vaccine for donation to the Africa CDC (Centres for...
management team, board of directors and scientific advisors have decades of experience in ophthalmic product development, FDA and EU submissions, approvals, and market commercialization. Joining Mitro is former Aerie executive Marvin Garrett as...
Biosyngen is proud to announce that the U.S. Food and Drug Administration (FDA) has approved its BRG01, an EBV-specific CAR-T cell therapy, to proceed with a pivotal Phase lI clinical trial. This marks the first cell therapy to enter Phase lI...
