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Sling Therapeutics is advancing the first late-stage oral drug for thyroid eye disease that, if approved, could compete against Amgen and Viridian Therapeutics.
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Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies.
Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed.
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Read our takes on the biggest stories happening in the industry.
Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.
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The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.
After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.
GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid the pharma’s recent $2.5 billion savings campaign.
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”
This guide explores the evolving role of podcasts, webinars, and thought leadership programs in biopharma and provides practical recommendations for public relations agencies, corporate communications teams, and commercial marketers looking to elevate their visibility and influence.
BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.
Analysts tentatively welcomed Novo’s new corporate rebrand—so long as it comes with a larger change to the company’s overall business strategy.
SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.