The Pharma Data

SEPTEMBER 28, 2021

In addition, results from Part 1 of Study SRP-9001-102, an ongoing, randomised, double-blind, placebo-controlled clinical test evaluating the security , efficacy, and tolerability of one dose of SRP-9001 in 41 boys with DMD, showed that the study met its primary biological endpoint of change in micro-dystrophin protein expression from baseline.

Clinical Trials 52

Clinical Trials Protein Expression Therapies FDA 52

Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression. And since proteins are often linked to disease, there's huge potential to treat a broad range of diseases with this technology. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

SEPTEMBER 10, 2020

Until the FDA approval of OCREVUS, there had been no FDA approved treatments for PPMS. About OCREVUS® (ocrelizumab) OCREVUS is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS, in addition to CIS in the U.S.)

Treatment 52

Treatment Disease FDA Approval Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Roche is therefore initiating two new Phase IIIb trials, one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE), which will evaluate a higher OCREVUS dose compared with the currently approved 600 mg dose, with both evaluated at the twice-yearly (six-monthly) dosing schedule. In 2019, Roche invested CHF 11.7

Clinical Trials 52

Clinical Trials Trials Disease FDA Approval 52

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Disease Treatment Therapies 52

The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively.

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

JANUARY 15, 2021

3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancer. Related Articles: Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History. 2,5 In the U.S., Cancer Stat Facts: Stomach Cancer. Posted: January 2021.

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Treatment Trials Disease Therapies 52