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...
Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...
of the trial expected by the end of 2024. Additionally, MTX-463 was granted orphan drug and fast track designations by the FDA, underscoring the potential of WISP1 to address significant unmet needs in treating rare fibrotic diseases, including...
Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing deal will include certain payments, including an upfront payment and milestone payments upon...
affects over 6 million Americans, is characterized by mouth mucous membrane inflammation, pain, and ulceration, and lacks FDA-approved treatments. Lipella's Phase 2a trial is a multi-center, dose-ranging study of LP-310, a proprietary...
Innocan Pharma Corporation a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that the FDA's Center for Veterinary Medicine (CVM) has granted the Company a sponsor fee waiver and assigned an Investigational New...
proposed claims and provides the substantiating evidence to its primary regulator, the U.S. Food and Drug Administration (FDA), and the agency works with Prolacta, where and if necessary, to refine the claim language. In response to a May 2024...
with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine...
Members of our founding and scientific teams previously developed the IMiDs, the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and we have applied...
