Regulatory

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FDA Issues Refusal to File Letter to Theratechnologies for sBLA Seeking Approval of Intramuscular Administration of Trogarzo

February 28th 2024

Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen.

Male lung cancer biopsy respiratory system in x-ray. 3d render
Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

February 28th 2024

FDA Rejects Minerva’s New Drug Application for Schizophrenia Treatment
FDA Rejects Minerva’s New Drug Application for Schizophrenia Treatment

February 28th 2024

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NY AG Requests FDA Review Safety Labeling on Singulair

February 28th 2024

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Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections

February 27th 2024

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