The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. Among study arm patients, 100 were hospitalized for heart failure or had a CV-related death, compared with 138 patients in the placebo arm. .

FDA Approval 52

FDA Approval FDA Pharmacokinetics Therapies 52

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. have Parkinson’s disease or a type of dementia called Lewy Body Dementia. Results found that 92.5

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

Therapies 52

Therapies Hospitals FDA Approval Long-Term Care Facilities 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. The FDA now states that “Studies to characterize the effect of extrinsic factors (e.g., supplemental oxygen, mechanical ventilation).

FDA 40

FDA Clinical Trials Vaccine Trials 40

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI. BioXcel Therapeutics, Inc.

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death.

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52