patients new therapies for high unmet medical needs." VOWST is the first and only U.S. Food and Drug Administration (FDA)-approved orally administered LBP used to prevent Clostridioides difficile (C.diff) infection in individuals people 18 years of...
to GMP on a single system — increasing throughput, improving quality, and reducing cost. Launched in 2024 and holder of an FDA Advanced Manufacturing Technology designation, IRO® is rapidly becoming the new standard in CGT manufacturing. About...
treatment due to adverse reactions. VYEPTI® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing...
— including an oral version of Rebecsinib that would broaden patient access. Clinical Progress Rebecsinib has received FDA Investigational New Drug (IND) approval (IND #153126), and recruitment for the Phase 1 trial in patients with high-risk...
Galvanize Therapeutics, Inc., a commercial-stage medical technology company pioneering pulsed electric field (PEF) therapies for oncology and chronic lung disease, today announced that it received U.S. Food and Drug Administration 510(k) clearance...
is the first and only non-replicating intravesical gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with high-risk BCG-unresponsive NMIBC with CIS, with or without papillary tumors (±Ta/T1), and is...
and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from...
health conditions before recommending individualized treatment plans. When clinically appropriate, providers may prescribe FDA-approved weight-loss medications, including GLP-1 therapies, alongside ongoing nutrition counseling and lifestyle...
organization (CDMO) specializing in mammalian cell-culture manufacturing. Headquartered in the U.S. with a flawless FDA record, Avid is trusted by biopharmaceutical innovators worldwide for its agility, quality, and ability to navigate complex...
Inc. (PTx), a private, fully integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic...
his tenure, Miach secured more than $60 million in funding, expanded commercial adoption of the BEAR Implant, and achieved FDA approval of key label updates to enable use in children and adolescents of any age and for partial ACL tears, as well as...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. U.S. sales of Tranexamic Acid Injection were approximately $30.2 million for the...
that delivers medications directly to customers' homes, is expanding access to Novo Nordisk's Ozempic® pill, the only FDA-approved oral GLP-1 medication to treat type 2 diabetes. Amazon Pharmacy will offer Same-Day prescription delivery and pickup...
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....
