The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. “The The speed and rigor with which Veklury has been developed and approved in the U.S.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

FDA Approval 40

FDA Approval Drugs Medicine Genetics 40

XTalks

JANUARY 26, 2024

Personalized medicine: One of the most exciting prospects of CRISPR/Cas9 in oncology is its contribution to personalized medicine. For example, a study published in Nature Medicine in 2020 reported on the safety and feasibility of using CRISPR-edited T cells in patients with refractory non-small-cell lung cancer (NSCLC).

Research 118

Research Gene Editing Gene Genetics 118

XTalks

MARCH 27, 2023

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

XTalks

APRIL 27, 2021

With the authorization, the IpsiHand System becomes the first non-invasive neurological rehabilitation device to receive FDA approval in the rapidly growing brain-computer interface space.

Radiology 105

Radiology Development FDA Approval Containment 105

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. There have been more than $1.7

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98