FDA sets PDUFA Action Date of June 28, 2025 ...
Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
The FDA has accepted a new drug application for the glioma-imaging agent Pixclara, with a decision expected next year. The Food and Drug Administration (FDA) has accepted a new drug application for ...
New hope could be on the horizon for ALS patients in the form of a "breakthrough" drug ... This month, Neuvivo submitted a new drug application (NDA) to the U.S. Food and Drug Administration ...
acceptance of the New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low ...
Standard components of the forms include the subject name, subject study number, and the names and contact information of the authorized prescribers of the study drug. The drug name, dosage ...
A new drug for people who have one of the worst forms of multiple sclerosis aims to make treatment much easier for patients. Ocrevus is a medicine commonly used to treat primary progressive MS ...
Oct. 09, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class ... New Drug (IND) application from the U.S. Food ...
The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. “With the acceptance of our New Drug Application for LNZ100, we are pleased to be one ...
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