tablets 1.5 mg, 4 mg, and 9 mg will be available for adults with type 2 diabetes in the US. Ozempic® is the only FDA-approved oral peptide GLP-1 medication for adults with type 2 diabete. Indicated not only to improve blood sugar, along with diet...
Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who...
health, pioneering innovative treatments that address long-overlooked needs. With the launch of Addyi, the first ever FDA-approved treatment for Hypoactive Sexual Desire Disorder (HSDD), Sprout helped shift the conversation around women's sexual...
that are now treated in hospitals," said Pieter Muntendam MD, founder, President and CEO of SQ Innovation. "Following FDA approval in the United States in 2025, these European regulatory milestones reflect our commitment to bringing this...
the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) and will begin commercial deployment of its FDA-cleared wound treatment, Hemastyl®, starting May 1, 2026. Clinical training across VA and DoD facilities will begin May 1,...
AbbVie announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for SKYRIZI® (risankizumab-rzaa) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely...
and comparable efficacy is expected. The ReSPECT study met its primary endpoint for US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards for fungal-free survival at Day 90, showing non-inferiority of rezafungin vs....
tissue-targeted regulatory T cell (Treg) therapies, today announced the receipt of U.S. Food and Drug Administration (FDA) clearance to initiate CK0801 Phase 2 clinical trial, for the treatment of aplastic anemia. Aplastic anemia, a rare and...
under-addressed neurological, endocrine, psychiatric and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal...
Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) approved IDVYNSO™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1...
– 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...
