Tags : FDA’s

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib +

Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 […]Read More

Inovio Reports FDA’s Partial Clinical Hold on P-II/III Trial of

Shots: The US FDA has put a partial clinical hold on P-II/III study of Inovio’s INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial because it has additional questions about the trial Inovio is actively working to address the FDA’s questions and plans to respond in Oct’2020 after which the FDA […]Read More

Subtle an AI based Medical Device SubtlePET Receives FDA’s 510(K)

Shots: SubtlePET is a medical device based on AI technology has received FDA approval, after EU approval. SubtlePET is used for medical imaging with rapid scans and utilizes algorithms that integrate with OEM scanner and picture archiving and communication system (PACS) The device enables to scan four times faster scans than current technology with improved […]Read More

Genentech’s Venclexta (venetoclax) Receives FDA’s Accelerated Approval for Patients with

Shots: The accelerated approval is based on M14-358 (P-Ib) & M14-387 study (I/II) results assessing Venclexta (400mg qd) + azacitidine & decitabine & Venclexta (600mg qd) + LDAC (low-dose cytarabine) respectively in patients with 1L AML. or for those ineligible for intensive induction CT aged ≥60 yrs. M14-358 & M14-387 study results: Venclexta + azacitidine […]Read More