Evaluate's annual analysis forecasts that the top 10 drug launches of 2026 could collectively generate $45.9 billion in annual sales by 2032 -- a significant leap from the $29 billion predicted for last year's launches. Leading the list are Novo Nordisk's CagriSema and Eli Lilly and Co.'s orforglipron, both to treat obesity and type 2 diabetes. The remaining drugs are projected to each achieve between $1.7 billion and $2.5 billion in annual sales, spanning indications such as multiple myeloma, dermatomyositis and hypertension. These launches reflect a surge in blockbuster potential, but much hinges on regulatory approvals anticipated throughout the year.

A "think small" strategy can be more effective for biopharma startups than aiming for blockbuster products, writes Bennett Smith, SVP of commercial for a biotech startup in stealth mode. Smith points to the success of Vertex Pharmaceuticals, Celgene and Argenx, which began with niche indications and gradually expanded their markets.

HHS has launched the $100 million Small Molecule Approaches for Rapid and Robust Treatment Prize to develop broad-spectrum antiviral therapies. The initiative is a collaboration between the BARDA and VITAL, BARDA's accelerator hub, and focuses on creating small-molecule antivirals for the Flaviviridae and Togaviridae virus families.

The FDA granted special designations to a number of oncology drugs in the first month of 2026. They include therapies for lung, liver, blood and pancreatic cancers.

BioNTech and Moderna diverged in their post-pandemic trajectories, with BioNTech expanding beyond mRNA into a multi-modality pipeline, particularly in cancer, while Moderna remained focused on mRNA vaccines. BioNTech's diversified approach has led to a stable market valuation of over $20 billion, supported by promising late-phase cancer candidates and significant partnerships, such as a $3.5 billion deal with Bristol Myers Squibb for pumitamig.

The FDA has granted breakthrough therapy designation to Biogen's litifilimab, a humanized immunoglobulin G1 monoclonal antibody for cutaneous lupus erythematosus. The designation was based on a Phase 2 study that found litifilimab resulted in significant improvements in disease severity scores.

The European Commission has proposed revisions to the Medical Device Regulation and the In Vitro Diagnostic Regulation that would clarify the classification of medical device software and artificial intelligence, potentially delaying the EU Artificial Intelligence Act. The changes aim to better align software classification with clinical risk and international standards, and include a lifecycle management approach and regulatory sandboxes.

Eli Lilly and Co. is set to build a new $3.5 billion manufacturing plant in Pennsylvania, marking its fourth new site in the US. This facility is part of the company's strategy to expand domestic production and strengthen its supply chain amid looming import tariffs.

Research published in the journal Clinical Infectious Diseases indicates that starting metformin around the time of acute COVID-19 infection may reduce the risk of long COVID by 40% to 60%, as shown across multiple studies and trials. The review emphasizes that timely administration is critical for maximizing the drug's preventive benefits.

A clinical trial reported in The New England Journal of Medicine found that adding palbociclib to standard treatment extended progression-free survival by about 15 months in patients with advanced triple-positive breast cancer. Researchers say the well-tolerated CDK inhibitor significantly improves disease control and could become a new first-line therapy for this hard-to-treat cancer.

Novo Nordisk's Phase 3 trial of CagriSema involved 2,734 patients globally, testing the efficacy of the drug in managing type 2 diabetes. The trial demonstrated superior blood sugar and weight reduction compared to semaglutide alone. Detailed data from this trial will be shared later in the year, providing further insights into its effectiveness and potential as a treatment option.

The FDA's Quality Management System Regulation is now in effect, replacing the Quality System Inspection Technique and aligning with ISO 13485:2016. While companies already familiar with international standards may find compliance straightforward, smaller firms and manufacturers of combination products might face challenges, says Kimberly Trautman, a medical device expert and former FDA official.

The European Parliament recently approved the Critical Medicines Act, and the law is expected to become effective this year, but the details of how it will be implemented are unclear. The law supports offering financial and regulatory incentives for relocating production to the EU, and immediate actions include joint procurement and sharing among EU member states. The European Parliament proposed a mandatory redistribution mechanism for stockpiled medicines, but the European Commission and the European Council have taken a less detailed approach.

Join us in Philadelphia, PA, June 14-18, 2026

Join global leaders, innovators, regulators, academics, and patient advocates in Philadelphia, PA, for the DIA 2026 Global Annual Meeting. As the life sciences industry continues to evolve, this event serves as a powerful platform to connect, collaborate, and drive forward transformative solutions. Be part of the conversations shaping tomorrow -- right in the heart of one of America"s most historic and inspiring cities. Registration is open.