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FDA Commissioner Marty Makary presented a new idea to staff this week: bonus payments for employees that complete regulatory review processes faster than expected.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Read our takes on the biggest stories happening in the industry.
Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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From biotech veterans to embattled modalities to a new wave of RNAi therapeutics, BioSpace’s NextGen Class of 2026 emerged during a tough fundraising environment in 2025. Check out the 15 battle-tested companies that caught our eye.
Recent breakthroughs and three decades of progress in treating Huntington’s disease
Arrowhead heralded the results as proof of concept that inhibiting the Activin E pathway can improve body composition and enhance weight loss as compared to tirzepatide alone, particularly in patients with type 2 diabetes.
Eli Lilly kicked off a pivotal 2026 campaign with a multi-year collaboration with current partner Nimbus Therapeutics worth a potential $1.3 billion for a preclinical obesity therapeutic. The deal follows a 2022 partnership struck by the companies to target the AMPK protein in cardiometabolic diseases.
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.
The agreement, which BMO Capital Markets called a “mild positive” for Structure, appears to address Roche’s concerns about the composition of investigational weight loss drug CT-996.
OncoNano’s platform, called ON-BOARD, packages drugs in pH-sensitive micelles that ensure their specific delivery near tumors, while also preventing systemic exposure.
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.