By Kevin Dunleavy
Following the FDA’s familiar playbook with a flurry of Friday afternoon approvals, the European Medicines Agency has signed off on several drugs, including Sanofi’s Xenpozyme, an enzyme replacement therapy for acid sphingomyelinase deficiency and Eli Lilly and Incyte’s Olumiant for alopecia areata.
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By Andrea Park
In the May 13 letter, the FDA upheld its initial decision to limit the Evo sEEG system’s use to just 24 hours at a time, noting that the company’s supporting evidence failed to prove that the device was substantially equivalent to other electrodes that have been cleared for longer wear periods.
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By Heather Landi
Women's health startup Tia is expanding its integrated care model to include fertility services with a focus on connecting family planning with counseling, preventive care and mental health support.
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By Nick Paul Taylor
Bayer is pulling the plug on its $670 million CAR-T pact with Atara Biotherapeutics. Three months after a death paused a study of the lead candidate, the German drugmaker has decided to cut its ties to Atara’s two mesothelin-directed CAR-T cell therapies.
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By Teresa Carey
This week on "The Top Line," we discuss what's left in the wake of Roche’s failed high-risk bet on an anti-TIGIT cancer drug. We also talk about Big Pharma’s growth in the first quarter and the week's biggest headlines. Plus, Fierce journalists share what it was like to finally be in a newsroom together again.
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By Conor Hale
iCAD’s ProFound program was one of the first pieces of AI cleared by the FDA for 3D mammography, an imaging method also referred to as digital breast tomosynthesis or DBT.
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By Robert King
A federal judge struck down a controversial Trump-era rule that required mandated drug makers to include copay assistance costs into Medicaid drug rebate calculations.
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By Annalee Armstrong
One hundred percent overall survival in just seven patients has provided the jet fuel needed by Rocket Pharmaceuticals to head to regulators for a rare childhood immunodeficiency disorder gene therapy. The company unveiled the phase 2 pivotal results from patients with severe leukocyte adhesion deficiency-I at the 25th Annual Meeting of the American Society of Gene and Cell Therapy Thursday.
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By Angus Liu
Several large pharma companies have joined hands with global health organizations in a new partnership that aims to improve access to essential cancer medicines in poorer nations.
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By Nick Paul Taylor
The FDA has sounded a warning about Foghorn Therapeutics’ blood cancer candidate FHD-286, putting a phase 1 clinical trial on a partial hold in response to the death of a patient with potential differentiation syndrome.
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By Paige Minemyer
Telehealth provider MeMD is changing its name to Walmart Health Virtual Care, marking one of the final steps in its integration into the retail giant's healthcare enterprise.
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