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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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The Janssen Pharmaceutical Companies of Johnson & Johnson announced longer-term results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of ciltacabtagene autoleucel, an investigational B-cell maturation antigen -directed chimeric antigen receptor T-cell therapy administered as a single infusion, in the treatment of patients with relapsed and/or refractory multiple myeloma.
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Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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Takeda told BioSpace that the California layoffs are directly related to the recent cuts in Massachusetts.
Novel therapies often pass through several owners on their way to the market. Here’s a look at some of the drugs that got dropped before they hit primetime.
Partnership seeks to identify novel therapeutic molecules to address diseases with high unmet patient needs. It’s the second target discovery company to link with BI in the last month.
The German biotech is trying to deepen its pipeline in cancer and other infectious diseases as COVID-19 markets contract and the international public health emergency comes to an end.
Weeks after announcing a CEO shake-up and slightly decreased Q1 revenues, BMS plans to cut 48 staff members from its Princeton, NJ, facility.
After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.
As competition eats away at profits for the wet age-related macular degeneration drug, Regeneron is diversifying its portfolio and pumping more money into research and development.
The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.
The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.