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Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees.
In a bid to improve competition in the industry, the U.S. Federal Trade Commission is challenging the patents of 20 different pharmaceutical products, disputing the accuracy and relevance of their patents.
Neurocrine Biosciences on Tuesday won the FDA’s approval for a sprinkle capsule formulation of Ingrezza, providing a more convenient route of treatment for Huntington’s disease patients with trouble swallowing.
This week’s legal losses by J&J and BMS reinforce the notion that Medicare drug price negotiation is here to stay, and investors continue to favor biologics over small molecules.
The FDA has cleared a clinical trial of an ex vivo prime editing candidate in patients with a rare disease, Prime Medicine announced Monday. The technique taps CRISPR technology to rewrite defective genes without breaking DNA double helix strands.
Under the latest teaming between the two companies, who have worked together since 2010, Novartis will pay $180 million upfront to PeptiDream to find new radioligand therapies.
Thanks to strong sales of its blockbuster drugs Mounjaro and Zepbound, Eli Lilly on Tuesday reported nearly $8.77 billion in revenue in the first quarter of 2024, while raising its full-year revenue guidance by $2 billion.
A federal court issued a summary judgment saying that the IRA provision does not represent an unconstitutional taking of property but did not rule on suits by Novartis and Novo Nordisk.
Based on strong overall and progression-free survival data in its Phase III confirmatory study, Pfizer and Genmab’s antibody-drug conjugate Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu significantly improved progression-free survival in metastatic breast patients with low and ultralow HER2 expression levels who had received at least one line of systemic treatment.