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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 that the U.S. FDA has approved two pediatric indications for XARELTO®: the treatment of venous thromboembolism and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
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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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Eli Lilly’s recently registered Phase IIIb SURMOUNT-5 trial will compare its Mounjaro with Novo Nordisk’s Wegovy in obese or overweight patients with weight-related health conditions.
The New York–based biotech will present data from a Phase I trial of 98 patients showing that fianlimab combined with Libtayo led to an overall response rate of 61% in advanced melanoma.
Bristol Myers Squibb’s Reblozyl induced nearly twice the red blood cell transfusion independence compared with the current standard treatment epoetin alfa for lower-risk myelodysplastic syndrome.
The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.
The Massachusetts-based biopharma became the second company this week to drop its amyotrophic lateral sclerosis hopeful after it failed to elicit significant improvement compared with placebo.
Although still in early-stage testing, Ensysce Biosciences’ formulation has demonstrated the potential to address addiction problems associated with oral oxycodone.
The AI drug discovery company’s reorganization will include laying off around 180 employees and dropping its atopic dermatitis candidate BEN-2293 in an effort to save nearly $56 million.
The investigational kinase inhibitor failed to improve overall survival in the SAPPHIRE study of patients with non-squamous non-small cell lung cancer, causing Mirati to discontinue its development.
The company’s candidate, ANX007, did not significantly slow lesion growth in a Phase II trial but was effective at preserving visual function in patients with a form of dry age-related macular degeneration.
The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.