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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.
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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.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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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, helmed by BioNTech alums, is developing therapies aimed at dermatological, respiratory and gut-related indications.
In its fourth-quarter earnings report, Moderna’s revenue was down substantially from 2023. Separately, media reports reveal anticipated cuts to the company’s digital team.
The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.
Amgen will continue to advance half of the combo, PRMT5 inhibitor AMG 193, for which it is running a mid-stage trial in MTAP-null advanced non-small cell lung cancer.
The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial.
Robert F. Kennedy Jr.—whose history of anti-vaccine rhetoric has had the healthcare and biopharma industries on edge—was confirmed as Health and Human Services Secretary in a Senate vote along party lines.
Encoded’s layoffs will mostly affect its technology and early-stage research and development functions. The move is expected to keep the biotech operational well into 2026.
Obesity drug developers Aardvark, Helicore and Metsera have all netted raises in the past two weeks.
Without providing specific data, Sanofi on Thursday announced that the experimental vaccine did not significantly prevent invasive E. coli disease versus placebo.
In this episode, presented by the Genscript Biotech Global Forum 2025, BioSpace’s Head of Insights Lori Ellis and Tom Whitehead continue to discuss the patient and caregiver experience, where Tom gives his insights to the future of CGTs.