Related Experiment Video
Updated: Jan 7, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
10.1K
Recent and anticipated novel drug approvals (4Q 2025 through 3Q 2026)
Brittany L Karas1, Mary Golf1, Elizabeth Shepard1
1Northwestern Medicine, Chicago, IL, USA.
Summary
Health-system pharmacists can prepare for upcoming novel drug approvals, focusing on therapies for rare diseases and cancer. This review highlights key drugs expected to impact hospital and clinic care within the next year.
Area of Science:
- * Pharmaceutical Science
- * Clinical Pharmacy
- * Health-System Pharmacy
Background:
- * Health-system pharmacists are vital for managing formularies and resources.
- * Monitoring the pharmaceutical pipeline is essential for optimizing new therapy integration.
- * Proactive updates support pharmacists in resource allocation and clinical program development.
Purpose of the Study:
- * To provide health-system pharmacists with updates on novel drug approvals.
- * To identify anticipated drug approvals with significant clinical and financial impact.
- * To support strategic planning for new therapies in hospital and clinic settings.
Main Methods:
- * Review of novel drugs awaiting US Food and Drug Administration approval.
- * Analysis focused on the 12-month period from Q4 2025 to Q3 2026.
- * Selection of drugs with anticipated significant clinical and financial impact.
Main Results:
- * 41 novel drugs are awaiting US Food and Drug Administration approval.
- * The pipeline includes therapies for rare diseases such as Wiskott-Aldrich syndrome and mucopolysaccharidosis type II.
- * Targeted cancer treatments and cell and gene therapies are prominent in the pipeline.
Conclusions:
- * Novel therapies are continuously enhancing the drug development pipeline.
- * Upcoming approvals are expected to significantly influence various disease state treatments.
- * Pharmacists are key to navigating the integration of these advanced therapies.
Keywords:
Food and Drug Administration drug approvalclinical trialsdrug approval processinvestigational drugsmedication developmentnew drug approvalsMore Related Videos
09:55Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
Published on: October 4, 2024
829
10:29Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors
Published on: May 9, 2025
2.1K
Related Concept Videos
01:26FDA Approved Drugs: Changes to Approved Drugs
222
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,...
222
01:11Clinical Trials: Overview
4.5K
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...
4.5K
01:26Drug Administration and Therapy Phases: Overview
1.1K
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...
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...
1.1K
01:25Drug Regulation
2.7K
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...
2.7K
01:28Drug Products: Biologics, Biosimilars and Interchangeables
214
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...
214
01:02Prescription, Nonprescription and Orphan Drugs
1.1K
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
1.1K