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ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identified through ongoing product monitoring, that could result in insulin under-delivery. This action is separate from the voluntary Medical Device Correction issued on March 12, 2026 affecting certain Omn...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced that data from its first-in-human Phase 1 study of MAR002 will be highlighted in an oral presentation at the 2026 Annual Meeting of the Endocrine Society (ENDO), being held from June 13-16 in Chicago, IL. MAR002 is a first-in-class alloster...

SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (Nasdaq: DXCM), the global leader in glucose biosensing, announced today through ongoing quality and accounting reviews it recently identified certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process, then sold by third parties. Scrapping limited amounts of sensors that do not meet Dexcom standards is a routine part of the company’s quality control process. Sensors identified...

WOODBURY, N.Y.--(BUSINESS WIRE)--BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced it will showcase its broad portfolio of ADME-Tox solutions and research expertise at several leading industry events, including the 2026 MPS World Summit and the ISSX 16th European Meeting. The MPS World Summit takes place May 26-May 29, 2026, in Washington, D.C. BioIVT colleagues will be available at booth #115 to discuss research...

SAN DIEGO--(BUSINESS WIRE)--Autobahn Therapeutics, Inc., a biotechnology company developing restorative treatments for people affected by neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to elunetirom, the Company’s lead candidate, for the adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults. Elunetirom is an oral, once daily, brain-penetrant, CNS thyroid hormone receptor...

LITTLETON, Mass.--(BUSINESS WIRE)--Mevion Medical Systems has signed a definitive purchase agreement to bring the MEVION S250-FIT Proton Therapy System™ to Tam Anh General Hospital in Vietnam. This would be the first proton therapy system in Vietnam. This signing reflects a broader shift in cancer care: proton therapy is becoming more practical to deploy, enabling more hospitals to bring advanced treatment closer to the patients who need it. Both the MEVION S250-FIT™ and MEVION S250i Proton The...

MORRISVILLE, N.C.--(BUSINESS WIRE)--NeoCircle validates Pathlight MRD ctDNA detection in early breast cancer, predicting progression months to years ahead of clinical progression...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotrans...

ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. This milestone represents yet another example of Galderma’s unique Integrated Dermatology stra...

WILMINGTON, Del.--(BUSINESS WIRE)--May 22, 2026 — AstraZeneca and Daiichi Sankyo’s DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval follows Priority Review by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented at the 2025 European Societ...