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Cingulate Files FDA New Drug Application for Lead ADHD Drug CTx-1301

Aug 7, 2025
Cingulate Inc., a biopharmaceutical company specializing in next-generation pharmaceutical products through its proprietary Precision Timed Release (PTR) technology, announced it has…
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Fresenius, Polpharma Biologics Ink Deal to Commercialize Vedolizumab Biosimilar

Aug 7, 2025
Fresenius Kabi is expanding its biopharmaceutical portfolio through a new global licensing agreement with Polpharma Biologics S.A., securing exclusive rights to commercialize the…
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FDA Expands Approval of AJOVY as First Anti-CGRP Preventive for Pediatric Episodic Migraine

Aug 7, 2025
In a significant development for pediatric migraine care, Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for AJOVY…
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FDA Approves Jazz Pharma’s Modeyso as First Treatment for Recurrent H3 K27M-Mutant Brain…

Aug 7, 2025
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric…
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The 3rd Spatial Biology for Drug Development Summit – *Free to Attend for Biopharma Experts

Aug 7, 2025
The 3rd Spatial Biology for Drug Development Summit Boston, MA | October 22-23, 2025 *Free to Attend for Biopharma Experts Spatial biology is at a turning point. Advances in…
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Astria, Kaken Ink Licensing Deal to Develop Navenibart for HAE in Japan

Aug 6, 2025
Astria Therapeutics, Inc. has entered into an exclusive licensing agreement with Kaken Pharmaceutical Co., Ltd., granting Kaken the rights to develop and commercialize navenibart in…
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Axplora Announces €6.5M Investment in Vizag Facility and FDA Inspection Success in India

Aug 6, 2025
Axplora, a global leader in API small molecule manufacturing, has announced a €6.5 million investment to expand production capacity at its Vizag site in India. This move aims to boost…
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SERB Pharmaceuticals to Acquire Y-mAbs Therapeutics in Strategic Deal

Aug 6, 2025
SERB Pharmaceuticals, a global specialty pharma company focused on rare diseases and medical emergencies, announced it has entered a definitive agreement to acquire Y-mAbs Therapeutics,…
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FDA Accepts Bristol Myers Squibb’s Priority Review for Breyanzi in Relapsed/Refractory Marginal Zone…

Aug 5, 2025
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene…
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Agios’ PYRUKYND (Mitapivat) Approved in Saudi Arabia for Adult Thalassemia Patients

Aug 4, 2025
Agios Pharmaceuticals, Inc. announced that the Saudi Food and Drug Authority (SFDA) has approved PYRUKYND (mitapivat) for the treatment of adult patients with non-transfusion-dependent…
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