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After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.
The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players are rethinking their strategies amid global supply chain disruption.
Galapagos at the start of the year had planned to split into two businesses, with one resulting entity focused on cell therapies. The biotech nixed these plans a few months later, instead choosing to put up for sale multiple cell therapy assets.
With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib.
In May, Summit released early data from the Phase III HARMONi study showing that while the PD-1/VEGF inhibitor resulted in significant progression-free survival improvements, it fell short of the overall survival bar.
The death occurred in a patient who had a complex medical background and who was being managed with several drugs, according to RBC Capital.
To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.
The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
Last month, investors’ hopes were dashed as Replimune suggested alignment had not yet been reached with the FDA on RP1’s future. Now, the regulator has accepted a refiled application after all.