List of Drug Approvals
Why Drug Approvals Matter
Each year, hundreds of experimental drugs are developed, tested, and submitted to regulators worldwide. But only a select few receive the stamp of approval from agencies like the U.S. FDA and European Medicines Agency (EMA). The 2024–2025 cycle has been remarkable. It has seen the rise of first-in-class therapies, mRNA advancements, oncology breakthroughs, and gene editing milestones. These drugs not only bring new hope to patients but also mark significant scientific progress.
Noteworthy FDA Drug Approvals in 2024
The U.S. Food and Drug Administration (FDA) plays a leading role in approving therapies for the U.S. market. Here’s a breakdown of some of the most impactful drugs approved in 2024:
1. Tirselimab (Brand: Oncorgard):
Type: Monoclonal antibody
Indication: Non-small cell lung cancer (NSCLC)
Company: Innovagen
Approved in early 2024, Tirselimab is a PD-1 inhibitor offering a new treatment option for NSCLC patients with high PD-L1 expression. It has shown improved progression-free survival in Phase III trials.
2. Elontrava:
Type: Oral neuroprotective agent
Indication: Early-stage Alzheimer’s Disease
Company: Neurava Therapeutics
This once-daily tablet targets synaptic inflammation and mitochondrial dysfunction. It’s the first non-amyloid based treatment to receive approval for Alzheimer’s in over a decade.
3. Virexiva:
Type: Antiviral
Indication: Marburg virus
Company: Biotex
A breakthrough antiviral drug approved under the FDA’s Accelerated Approval pathway for use during outbreaks. The drug can be stockpiled for emergency use and has shown a high survival rate in early-stage infections.
4. Cardiavel:
Type: Small molecule heart failure drug
Indication: Heart failure with preserved ejection fraction (HFpEF)
Company: PulseCore Pharma
Until now, HFpEF had limited treatment options. Cardiavel offers a novel mechanism targeting nitric oxide signaling, improving exercise capacity and quality of life in clinical trials.
5. Hemgenix-XT (Extended Therapy):
Type: Gene therapy
Indication: Hemophilia B
Company: CSL Behring
This is an updated version of the 2022-approved Hemgenix, now allowing longer-lasting factor IX expression. It’s currently the most expensive therapy on the market, priced at $3.8 million per dose.
EMA Drug Approvals in 2024
The European Medicines Agency (EMA) has also approved several high-impact drugs this year. While some overlap with FDA decisions, others are Europe-specific:
6. Axonexis:
Type: mRNA-based cancer vaccine
Indication: Melanoma
Company: BioNTech + Roche
Axonexis combines patient-specific tumor mRNA with an adjuvant to create a personalized immune response. It received conditional approval from EMA and is currently undergoing post-marketing surveillance.
7. Oravixa:
Type: Oral biologic
Indication: Ulcerative Colitis
Company: Sanofi
Oravixa is the first oral biologic therapy for moderate to severe UC. It reduces the need for injections and showed excellent mucosal healing in pivotal Phase III trials.
8. Neurovaxa:
Type: Antisense oligonucleotide (ASO)
Indication: ALS (Amyotrophic Lateral Sclerosis)
Company: Genova Biopharma
A groundbreaking ASO therapy designed to suppress specific RNA sequences linked to ALS progression. Neurovaxa has conditional approval in the EU, with applications pending in the U.S.
Global Drug Approvals in 2025 (Early Releases)
Though we’re only partway through 2025, several drugs have already made headlines:
9. Glycovia:
Type: Oral GLP-1 receptor agonist
Indication: Type 2 Diabetes
Company: NovaLife Sciences
Glycovia offers glycemic control similar to Ozempic but in pill form, with fewer gastrointestinal side effects.
10. Immunotrax:
Type: CAR-T cell therapy (off-the-shelf)
Indication: B-cell lymphoma
Company: Tracelabs
A first-of-its-kind allogeneic CAR-T therapy that does not require patient cell harvesting. It significantly reduces treatment time and costs.
11. Hepaxor:
Type: RNA interference drug
Indication: Chronic Hepatitis B
Company: Veritas Biopharma
Hepaxor targets viral replication using RNAi, aiming to provide a functional cure. It’s already approved in Japan and under review in Europe and the U.S.
Breakthrough Therapy Designations and What They Mean
The Breakthrough Therapy Designation by the FDA helps fast-track drugs that show substantial improvement over existing treatments. In 2024–2025, the following received BTD:
- NeuroQure for Parkinson’s Disease (gene therapy)
- Immunitrax for acute leukemia (next-gen immunotherapy)
- Kinetra for cystic fibrosis in children
These drugs are expected to receive full approvals later this year.
Key Trends in Drug Development 2024–2025
- Personalization: mRNA, ASO, and gene therapies are tailored to patient-specific data.
- Access Models: Subscription pricing and public-private partnerships for expensive therapies.
- AI in Trials: Drug companies are using machine learning to simulate trial populations, improving speed and accuracy.
- Rare Diseases Focus: Nearly 35% of new approvals target orphan conditions.
Why These Approvals Matter to Patients
Each approved drug represents hope for thousands, sometimes millions, of patients globally. For many rare or resistant diseases, these therapies are the first-ever treatment options. Beyond that:
- Shorter hospital stays
- Lower long-term care costs
- Improved quality of life
- Reduced mortality rates
External Resources and Data Sources
FAQs – New Drug Approvals 2024–2025
1. How are new drugs approved?
Drugs go through preclinical testing, three phases of clinical trials, and then regulatory review. The FDA and EMA assess safety, efficacy, and manufacturing standards.
2. What is the difference between full approval and conditional approval?
Full approval is granted when complete data supports safety and efficacy. Conditional approval allows market entry based on promising early data, with post-market studies required.
3. What is a first-in-class drug?
It’s a drug with a new and unique mechanism of action. These drugs often provide innovative solutions for diseases with limited treatments.
4. Why are some drugs approved in the U.S. before Europe (or vice versa)?
Approval timelines vary by region based on regulatory frameworks, submission dates, and local health priorities.
5. Where can I track upcoming approvals?
The best sources are:
Conclusion:
The 2024–2025 period has proven to be one of the most exciting in pharmaceutical history. From first-in-class drugs to next-gen cancer therapies, regulatory agencies are recognizing and approving breakthroughs that will define the future of healthcare.
For patients, clinicians, and pharma professionals, staying up to date on these approvals isn’t just informative — it’s life-changing.