Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Drug Administration and Therapy Phases: Overview

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019

Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2018

Search research articles

Related Experiment Video

Updated: Feb 23, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Pharmaceutical Approval Update.

Michele B Kaufman

P & T : a Peer-Reviewed Journal for Formulary Management

|September 12, 2017

Summary

This summary is machine-generated.

Three new drug approvals offer hope for patients with rheumatoid arthritis, tardive dyskinesia, and a rare genetic disorder. These advancements provide novel treatment options for challenging conditions.

More Related Videos

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

Related Experiment Videos

Last Updated: Feb 23, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

Published on: November 29, 2024

Area of Science:

Pharmacology and Therapeutics
Neurology
Rheumatology

Background:

Rheumatoid arthritis (RA) is a chronic autoimmune disease causing joint inflammation.
Tardive dyskinesia (TD) is a movement disorder often associated with antipsychotic medications.
Late infantile neuronal ceroid lipofuscinosis type-2 disease (LINCL-2) is a rare, fatal genetic disorder.

Purpose of the Study:

To announce the approval of Sarilumab (Kevzara) for RA.
To highlight the first-ever approval of Valbenazine (Ingrezza) for TD.
To report the approval of Cerliponase alpha (Brineura) for LINCL-2.

Main Methods:

Review of clinical trial data supporting efficacy and safety.
Regulatory review process by health authorities.
Assessment of therapeutic benefit in target patient populations.

Main Results:

Sarilumab (Kevzara) demonstrated efficacy in treating moderately to severely active RA.
Valbenazine (Ingrezza) received approval as the first treatment for TD.
Cerliponase alpha (Brineura) was approved for patients with LINCL-2.

Conclusions:

These approvals represent significant advancements in medical treatment.
New therapeutic options are now available for RA, TD, and LINCL-2.
These novel drugs offer improved management and potential disease modification.