Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. The National Institutes of Health (NIH) Clinical Collection , a library of FDA-approved drugs, is widely used for HTS in drug repurposing initiatives.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. About Rivaroxaban (Xarelto ) Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

NOVEMBER 26, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Galactosidase-A enzyme.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

DECEMBER 29, 2020

“We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application.” Galactosidase-A enzyme. Protalix has licensed to Pfizer Inc.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments. billion for pseudoephedrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

APRIL 11, 2021

Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. Retevmo (marketed as Retsevmo ® outside the U.S.) was approved by the European Commission in February 2021. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

JANUARY 21, 2021

ViiV Healthcare is the marketing authorization holder for CABENUVA. Janssen is the marketing authorization holder for EDURANT ® in the U.S. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. In the U.S.,

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

APRIL 27, 2021

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. About the Phase 1/2 Trial.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

The Pharma Data

MARCH 16, 2021

TREMFYA q4w is not currently FDA-approved. Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®. About Psoriatic Arthritis.

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. 59% of infants were able to sit without support for at least 5 seconds. No new safety signals were identified.

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. In post marketing experience, QT prolongation, and torsades de pointes have been observed in patients who develop hypokalemia while taking ZYTIGA ®. 2 ERLEADA ® received U.S.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Advarra

DECEMBER 14, 2022

FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Other devices, such as premarket approvals (PMAs) and 510ks, are not considered as qualifying clinical trials and do not require research modifiers to be eligible for coverage. drugs and biologicals.

Clinical Trials 52

Clinical Trials Trials Compliance FDA Approval 52

The Pharma Data

SEPTEMBER 1, 2020

Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

New Drug Approvals

APRIL 21, 2025

18] Society and culture Legal status Acoramidis was approved for medical use in the United States in November 2024. [6] 6] [7] [19] The approval was granted to BridgeBio Pharma. [10] Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S. PMC 6276790.

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FDA Approval FDA Production Treatment 57

Metabolite Tales Blog

FEBRUARY 7, 2025

As a result theres been much excitement around the recent FDA approval of Vertexs suzetrigine as a first-in-class non-opioid treatment for management of acute pain. Suzetrigine (marketed as Journavx) selectively blocks the Na V 1.8 Gender difference in the pharmacokinetics and metabolism of VX-548 in rats. 2022;13:874606.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Clinical Trials Trials 52

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. In South Africa, there are about 150,000 new HIV infections each year.

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