gives us confidence to persevere harder than ever, and positive interactions with the US Food and Drug Administration (FDA) confirm that we are on the right track. Our team is motivated and driven to progress SAR-bisPSMA to the market through the...
to giving life to science and transforming innovation into value, announced that the U.S. Food and Drug Administration (FDA) and European Commission have granted Orphan Drug Designation to deupirfenidone (LYT-100) for the treatment of idiopathic...
data from RSV season 1 of the Phase 3 SMART trial — alongside data from the pivotal Phase 2b/3 CLEVER trial—supported the FDA approval of ENFLONSIA in June 2025 and subsequent global regulatory approvals. Interim data from RSV season 1 of the SMART...
large volume subcutaneous infusion solutions, announced that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a therapy...
Designation" from both the Center for Drug Evaluation (CDE) of the China NMPA and the U.S. Food and Drug Administration (FDA). Guidelines from the World Health Organization (WHO) and the European Association for the Study of the Liver (EASL)...
Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with...
care measures are therefore an important part of managing patients receiving cancer therapy." Zolbetuximab (VYLOY) is an FDA approved monoclonal antibody for patients with HER2-negative, CLDN18.2-positive advanced gastric or GEJ cancer. In...
Octapharma USA, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired...
gastrointestinal tract, supporting sustained therapeutic exposure throughout the day. Aizhida was approved by the U.S. FDA in March 2021 as a once-daily treatment option for patients with ADHD 6 years of age and older. ADHD is a common, chronic...
of ALS (ClinicalTrials.gov Identifier: NCT 07161999). COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq:...
by extremely fragile bones, skeletal deformities, pain, and reduced quality of life. There are currently no EMA or FDA approved disease-modifying treatments for OI, and existing interventions are largely palliative. By enabling early intervention,...
across four brain regions—an order-of-magnitude increase over commercially available devices. The NeuroPace RNS system, FDA-cleared for epilepsy, records from up to six channels; Medtronic's Percept adaptive DBS system records from up to four. This...
in ophthalmology. Eydenzelt was also approved by the European Commission (EC) and the U.S. Food and Drug Administration (FDA) in February and October 2025, respectively. About Eydenzelt® Eydenzelt® is a vascular endothelial growth factor (VEGF)...
hematologic malignancies, where more effective treatment options are desperately needed." ELZONRIS was approved by the FDA in December 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients...
the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting...
Arrowhead Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved REDEMPLO (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial...
(dordaviprone) Modeyso (dordaviprone) (formerly known as ONC201) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with...
recent submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval to include new evidence in the TREMFYA® label for the inhibition of progression of structural damage in adults with...
(UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in...
PRM Pharma, LLC announces the nationwide availability of HemiClor® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults. This milestone comes as the...
