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FDA Grants Breakthrough Status to Izalontamab Brengitecan for EGFR-Mutant Lung Cancer

Aug 19, 2025
SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan…
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Boehringer Ingelheim, Palatin Technologies Partner to Develop Melanocortin Receptor Therapy for…

Aug 18, 2025
Boehringer Ingelheim and Palatin Technologies, Inc. have announced a global research collaboration and licensing agreement to develop a novel treatment targeting retinal diseases. This…
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Precigen’s PAPZIMEOS Gets Full FDA Approval for Recurrent Respiratory Papillomatosis

Aug 18, 2025
Precigen, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba), the first and only FDA-approved treatment…
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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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