Key Medicines in Line to Storm the Market This Year

With 2024 bringing 50 new drug approvals, the pharmaceutical sector is poised to continue its streak. And the launch of every new treatment offers a light of hope for countless patients around the world.

The highly awaited drugs for 2025 revolve around a few key disease areas that are yet to see leaps in progress, including oncology, neurodegeneration, rare diseases, and cardiovascular health. And with regulatory agencies like the DHHS (that governs the FDA) under new leadership, the biopharma industry is adapting to evolving regulatory standards and requirements. Here we unveil the most anticipated launches of the year.

A Year in Review

While 2024 saw major interest in obesity driven by next-generation GLP-1 therapies, dozens of other approved medicines have revolutionized disease areas that haven’t seen significant progress in years.

Among 2024’s most notable approvals were Cobenfy (a fixed-dose combination therapy for schizophrenia and the first novel mechanism of action for the disease in years), Revuforj (for acute leukemia), and multiple cell therapies for the treatment of solid tumors. Oncology has remained a priority for drug developers, with cancer drugs comprising 30% of medicines approved in 2024. Further, 32 of the 50 drugs approved are small molecules (including peptides of up to 40 amino acids in length). The agency also approved a record number of cell and gene therapies, like Lifiluecel (Amtagvi) and Lenmeldy.

A Look Forward

Oncology

Only a month into the year, the FDA has already approved three oncology drugs and combination therapies, including acalabrutinib (Calquence) for lymphoma and sotorasib (Lumakras) with panitumumab (Vectibix) for metastatic colorectal cancer. On January 17, the FDA approved datopotamab deruxtecan-dln (Datroway), an antibody and topoisomerase inhibitor conjugate, for patients with HR- and HER2- breast cancer.

Additionally, the FDA has granted fam-trastuzumab deruxtecan-nxki (Enhertu) priority review for patients with HER2-low or HER2-ultra low metastatic breast cancer, meaning a faster decision from the FDA. Estimates show that 85% of patients with metastatic hormone receptor-positive breast cancer may benefit from the drug, and an FDA decision is expected in the first quarter of 2025. Two more drugs, Lynparza and Xpovio, are being studied for therapeutic potential in endometrial cancer, in combination with immunotherapy.

Anti-Obesity & Weight Loss

In a combination of its own semaglutide (Wegovy) with an amylin agonist (cagrilintide), Novo Nordisk’s CagriSema is another fixed-dose therapy that aims to treat obesity. Encouraging phase 3 clinical study results show significant weight loss with the drug, and may hint at an approval later in the year. While the FDA has already approved semaglutide for treatment of Type II Diabetes (Ozempic) and weight loss (Wegovy), its NDA holder is seeking two new indications in 2025: chronic kidney disease and metabolic dysfunction-associated steatohepatitis.

Other notable drugs include nipocalimab, currently being reviewed for generalized myasthenia gravis (a chronic autoimmune disease causing muscle weakness). Further, the drug was granted a ‘breakthrough therapy’ designation for two other indications, including Sjögren’s and HDFN.

As we look ahead to 2025, the healthcare and biotech industries are poised to continue transforming the way we prevent, diagnose, and treat diseases. By embracing these advancements, increasing access, and prioritizing patient-centric care, the future looks brighter than ever before.

Read more about why drug repurposing can discover benefits to existing medicines or why the antiobesity market is anticipated to reach over $100 billion by 2030. Subscribe to our newsletter for the latest.

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