Tag: NDA
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Cogent Biosciences Submits New Drug Application to Advance Precision Therapies
Cogent Biosciences Submits New Drug Application to Regulatory Authorities Cogent Biosciences, Inc., a Waltham, Massachusetts and Boulder, Colorado-based biotechnology company focused on precision therapies for genetically defined diseases, announced on December 30, 2025, that it has submitted a New Drug Application (NDA) for its lead therapy. The submission marks a pivotal milestone for the company…
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Cogent Biosciences Submits New Drug Application for Genetic Diseases
Cogent Biosciences Announces Submission of New Drug Cogent Biosciences, Inc., a biotechnology company focused on precision therapies for genetically defined diseases, announced today that it has submitted its New Drug submission to the relevant regulatory authorities. This milestone marks a key phase in the company’s effort to bring targeted, mechanism-based treatments to patients who currently…
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Cogent Biosciences Submits New Drug Application to FDA
Cogent Biosciences Advances Precision Medicine with New Drug Application Submission Cogent Biosciences, a biotechnology company dedicated to developing precision therapies for genetically defined diseases, announced today that it has submitted a key regulatory document for its latest therapeutic candidate. The submission marks a significant milestone in Cogent’s mission to bring targeted treatments to patients who…
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HUTCHMED Wins Priority NDA Acceptance in China for Savolitinib-Based MET Inhibition Therapy
HUTCHMED Advances Savolitinib with Priority NDA Acceptance in China HUTCHMED, a global biopharma company focused on oncology and immunology, announced that the National Medical Products Administration (NMPA) in China has accepted its new drug application (NDA) for Savolitinib with priority review status. This move follows the company’s recent positive Phase II registration study data in…
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Hutchmed Wins Priority NDA Acceptance in China for Savolitinib After Positive Phase II Data
Overview: Hutchmed Moves Forward with Savolitinib in China Hutchmed (Hydrogenated Medicine) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Savolitinib with priority review. This milestone follows a sequence of supportive data, including a positive Phase II registration study conducted in Chinese patients and a 2023 Breakthrough…
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Nishant Kumar Breaks Silence: Inside the NDA Bihar Poll Landslide and Its Impact
Introduction: A Quiet Champion Behind a Historic Win The NDA’s sweep in Bihar marked a watershed moment in the state’s political landscape, with Chief Minister Nitish Kumar securing a record 10th term. In a rare public appearance, Nishant Kumar, Nitish Kumar’s son, stepped forward to address the moment and offer his reflections on the landslide…
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Nishant Kumar Talks NDA Bihar Landslide: Rare Exclusive Interview
Introduction: A Rare Window into Bihar’s Political Moment When Nitish Kumar was sworn in for a record 10th term as Bihar’s chief minister, the political spotlight naturally fell on the veteran leader. Yet in a rare turn, his son Nishant Kumar stepped into the limelight, breaking years of public silence to speak about his father’s…
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Bihar Poll Rout Shocks Lalu: Rohini Yadav quits politics and disowns the family
Overview: A dramatic exit amid Bihar’s political shakeup The political tremors in Bihar have taken a personal turn as Rohini, daughter of veteran leader Lalu Prasad Yadav, announced she is quitting politics and publicly distancing herself from the family’s political legacy. The timing could not be more symbolic: the NDA’s resurgence in the state has…
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Rohini Yadav Quits Politics, Disowns Family Following Bihar Poll Setback
Overview In a surprising political pivot, Rohini, the daughter of influential Bihar politician Lalu Prasad Yadav, has announced her departure from politics and publicly disowned her family. The move comes in the wake of a decisive Bihar election result that saw a significant swing away from the Rashtriya Janata Dal (RJD) and a resurgence for…
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NDA Victory in Bihar Signals Broad National Ripple Effects
Bihar Victory and Its National Read Across The National Democratic Alliance’s sweeping victory in Bihar is being hailed as a strategic reset for national politics. While the win is rooted in local issues—the economy, development projects, and administration—its scale, reminiscent of the 2010 mandate, may push the party to recalibrate its approach on a broader…