Bayer announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to...
and clinical development of its groundbreaking technologies. In 2022, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device status to XT-ViVo® and TimeSeal® for human kidney preservation up to 120 hours for transplant. For more...
with wAIHA, a rare, life-threatening condition for which patients currently have no U.S. Food and Drug Administration (FDA)-approved treatment options. "These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable...
pain remains especially urgent. The company has initiated an additional pivotal U.S. Phase 3 trial to support a future FDA submission. Based on the current development plan, the company anticipates a first data read-out in 2027 and, subject to...
TelyRx Holdings Inc. a technology-enabled healthcare and online pharmacy platform focused on expanding access to FDA-approved medications across the United States, today announced it has surpassed one million prescriptions filled nationwide since...
the single-use neuro-endoscope, has officially received certification from the Taiwan Food and Drug Administration (TFDA), marking an important milestone in the company's development in medical imaging and endoscopic applications. Following its...
Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved XOCOVA® (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and...
new EC approval reinforces the expanding impact of Opdivo in cHL, building upon the U.S. Food and Drug Administration (FDA) approval of Opdivo in combination with AVD for previously untreated Stage III or IV cHL in adults and pediatric patients 12...
precision medicine company, announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA® (talazoparib) in...
Mr. Pitts is a globally recognized expert in healthcare policy, regulatory science, and U.S. Food and Drug Administration (FDA) governance. He previously served as Associate Commissioner at the FDA and as a member of the U.S. Senior Executive...
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...
