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FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs. This novel HIV t...

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying con...

VENLO, Netherlands & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the commercial launch of QIAsymphony Connect, an IVD-compliant platform for automated clinical nucleic acid extraction. Building on the trusted QIAsymphony platform, with more than 3,300 cumulative placements worldwide, QIAsymphony Connect helps clinical laboratories standardize extraction across diverse assay workflows. The platform delivers highly concentrated DNA and...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (m...

WEST CHESTER, Ohio--(BUSINESS WIRE)--LetsGetChecked now offers the most comprehensive FDA-cleared at-home HPV screening tool available in the U.S....

MIAMI & LEAWOOD, Kan.--(BUSINESS WIRE)--The American Medical Society for Sports Medicine (AMSSM) and OpenEvidence today announced a partnership that will focus on co-developing AI-powered educational resources on sports medicine for both patients and clinicians. This exclusive collaboration brings the expertise of AMSSM’s sports medicine physicians to OpenEvidence, the leading AI-powered clinical decision support platform, and will build on the AMSSM’s robust foundation of educational materials....

LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir (DTG)), for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor (INSTI)-naïve) weighing at least 2 kg. Diana F. Clarke, Pharm.D., As...

AUSTIN, Texas--(BUSINESS WIRE)--Paradromics Inc., a leader in neurotechnology and developer of the world’s highest-data-rate brain-computer interface platform, today announced that it has received an approval letter from the U.S. Food and Drug Administration (FDA) expanding the types of computing devices that may be used with its investigational BCI system. The approval creates a pathway for Paradromics to support compatible personal, internet-connected devices through Convey™, its user-facing s...

EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Cronus Pharma LLC, a veterinary pharmaceutical company focused on developing high-quality, cost-effective animal health products, today announced the U.S. launch of Robenacoxib Injection, the only FDA-approved bioequivalent to ONSIOR® (robenacoxib) Injection. Robenacoxib Injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs ≥ 4 months of age, and with orthopedic surgery, ovariohysterectomy...

NEW PRAGUE, Minn.--(BUSINESS WIRE)--Electromed, Inc. Announces Record Fiscal 2026 Fourth Quarter and Full Year Financial Results...