– Eli Lilly Company's newest oral GLP-1 innovation – on the Ro platform, adding to Ro's already comprehensive formulary of FDA-approved GLP-1s. Foundayo™ is a once daily oral treatment for adults with obesity or overweight with weight-related...
Dexcel Pharma USA is pleased to announce that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic equivalent of...
the lives of patients through high-precision cell therapy, announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with...
dose, as supported by recent dose-optimization work (Project Optimus), shared with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The primary endpoint is overall response rate, with secondary endpoints including...
Johnson & Johnson a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of...
per the clinical trial protocol. Based on data from the LITESPARK-011 trial, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review seeking approval for WELIREG plus LENVIMA for the...
and facilitates ongoing engagement with regulatory authorities, including the U.S. Food and Drug Administration (FDA), as the trial progresses. Professor Merit Cudkowicz, Principal Investigator, HEALEY ALS Platform Trial & Director, Sean M. Healey...
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)...
