“Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint ...
Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...
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FDA accepts Otsuka’s centanafadine application for ADHD treatment
The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...
Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its ...
The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...
Imagion Biosystems has submitted an Investigational New drug Application with the US FDA for its MagSense imaging agent for ...
On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...
The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...
The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial ( NCT07285070) in ...
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