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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.

After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.

Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.

In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.

Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.

The fierce rivalry between Novo Nordisk and Eli Lilly is alive and well, as the two companies are expected to face off with their new obesity pills this year.

After getting the crucial first-mover advantage with an FDA approval for a weight loss pill, Novo Nordisk looks to win the market before rival Lilly can arrive with its own oral option for obesity.

• Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26 • Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26 • Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027 • Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the second half of 2026

34-acre campus supports 200,000 square feet of GMP manufacturing, with long-term expansion capacity exceeding one million square feet