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Kexing Biopharm Partners with IQVIA to Drive Global Expansion

Aug 12, 2025
Kexing Biopharm has announced a strategic partnership with IQVIA, a global leader in clinical research and healthcare intelligence, to accelerate the international development and…
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Viatris Receives FDA Approval for First Generic Iron Sucrose Injection in U.S.

Aug 12, 2025
Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Iron Sucrose Injection, USP, the first generic version of Venofer Injection. This intravenous…
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FDA Grants Accelerated Approval to Boehringer’s HERNEXEOS for HER2-Mutant Lung Cancer

Aug 12, 2025
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to HERNEXEOS (zongertinib tablets), Boehringer Ingelheim’s new oral targeted therapy for adults with…
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FDA Grants Priority Review to Gepotidacin for Oral Treatment of Gonorrhea

Aug 12, 2025
GSK announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for gepotidacin, an oral antibiotic, for the treatment of…
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Sartorius Stedim Biotech and Nanotein Partner to Boost Cell Therapy Manufacturing

Aug 12, 2025
Sartorius Stedim Biotech, a leading provider of solutions for the biopharmaceutical industry, has announced a new strategic partnership with Nanotein Technologies, a California-based…
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FDA Accepts Arvinas’ NDA for Vepdegestrant in ER+/HER2- Breast Cancer with ESR1 Mutation

Aug 11, 2025
Arvinas, Inc., in partnership with Pfizer, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel oral…
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Ono and Seikagaku Partner to Co-Develop and Market Gel-One for Osteoarthritis in Japan

Aug 8, 2025
Ono Pharmaceutical Co., Ltd. announced that it has entered into a definitive agreement with Seikagaku Corporation to co-develop and exclusively market Gel-One, Seikagaku’s…
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CorMedix to Acquire Melinta, Expanding Acute Care Portfolio

Aug 8, 2025
CorMedix Inc. and Melinta Therapeutics LLC announced a definitive agreement for CorMedix to acquire Melinta. The selling shareholders will receive $300 million in total consideration at…
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Valneva: FDA Lifts Pause on IXCHIQ for Elderly, Updates Prescribing Info

Aug 8, 2025
Valneva SE announced that the U.S. Food and Drug Administration (FDA) has lifted its previously recommended pause on the use of the company’s Chikungunya vaccine, IXCHIQ, in individuals…
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Genmab’s EPCORE FL-1 Trial Meets Goals in R/R FL

Aug 8, 2025
Genmab A/S announced promising Phase 3 results from its EPCORE FL-1 clinical trial, which evaluated epcoritamab—a subcutaneous bispecific antibody—combined with rituximab and…
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