The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

FDA Approval 52

FDA Approval Vaccination Vaccine Genetics 52

Drug Discovery World

NOVEMBER 29, 2023

These findings closely matched the results of the corresponding real-life clinical trials. The most important benefit is that we now have an accurate model that we can use to perform virtual experiments with different types of interventions, quickly and digitally.”

Development 52

Development Drugs Radiology Drug Trials 52

XTalks

MARCH 27, 2023

The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. Rezafungin met the endpoints outlined by both the EMA and FDA. For example, Scynexis Inc.

Clinical Trials 98

Clinical Trials Clinical Trials Branding Trials 98

XTalks

JANUARY 26, 2024

Clinical trials have demonstrated the potential of CRISPR/Cas9 in this field. As of October 19, 2023, there were 692 FDA-approved devices linked to AI/ML , underscoring the expanding role of these technologies in healthcare.

Research 118

Research Gene Editing Gene Genetics 118

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. Neurolutions submitted clinical data to the FDA for evaluation of safety and effectiveness of the IpsiHand System device.

Radiology 105

Radiology Development FDA Approval Containment 105

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

Trials 83

Trials Drug Delivery Drugs Gene 83

Drug Discovery World

APRIL 14, 2023

Carolyn R Bertozzi, PhD – Outstanding Achievement in Chemistry in Cancer Research Bertozzi is the Baker Family Director of Sarafan ChEM-H, the Anne T and Robert M Bass Professor in the School of Humanities and Sciences, Professor of Chemistry and, by courtesy, of Chemical and Systems Biology and of Radiology at Stanford University.

Genetics 52

Genetics Research Medicine Clinical Research 52

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

Drugs 40

Drugs FDA Approval Marketing Containment 40

XTalks

JUNE 12, 2023

The growth is attributed to regulatory approvals, strategic partnerships and the acquisitions of innovative medical technology companies. Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. The company reported an investment of $2.7 billion ($22.83 billion USD), a 20.65

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66