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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the Phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil). The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. For the key secondary end...

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology will issue its 1Q-2025 results after market close on May 8, 2025, and follow with a conference call at 1:30 pm PT/4:30 pm ET....

LOS ANGELES--(BUSINESS WIRE)--A novel combination therapy offers better outcomes for patients with KRAS G12C metastatic colorectal cancer, according to a City of Hope study....

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Isolere Bio by Donaldson, an innovative bioprocessing technology provider, proudly announces the availability of its manufacturing-grade IsoTag™ AAV reagent for the purification of Adeno-associated Virus (AAV) vectors. As indicated during the launch of the research-grade reagent in October 2024, this final advancement in product grade now includes production with validated processes and the availability of a full suite of documentation, including a...

LA JOLLA, Calif.--(BUSINESS WIRE)--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that the company has received feedback from its Type D meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for Accelerated Approval, as well as the company’s filing for Breakthrough Therapy designation for...

PARSIPPANY, N.J.--(BUSINESS WIRE)--U.S. FDA Approves Second Drug Product Manufacturing Facility for ADSTILADRIN (nadofaragene firadenovec-vncg)...

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the US, as well as the price and market share trends since each biosimilar’s launch. “The first quarter of 2025 has witnessed substantial developments in market competition and regulatory paradigm. Among the most significant mil...

AUSTIN, Texas--(BUSINESS WIRE)--Gameto Announces First U.S. Clinical Site Open for Enrollment in Fertilo Study...

IRVING, Texas--(BUSINESS WIRE)--The latest Medical Device Tech Watch also reviews emerging trends in cardiovascular and peripheral interventions....

SCHAUMBURG, Ill.--(BUSINESS WIRE)--MDDAP is empowering professionals with new opportunities to excel in the medical device sector through a cutting-edge learning pathway designed for the Voluntary Improvement Program (VIP). This initiative provides essential certifications leveraging the Medical Device Discovery Appraisal Program (MDDAP), equipping appraisers to grow in their careers, access new revenue opportunities, and contribute to continuous improvement efforts within the industry. MDDAP i...