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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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Roche’s Genentech is betting on the Flagship Pioneering–founded company’s discovery platform called DECODE to find new targets for an undisclosed autoimmune disorder.
The so-called ‘Most Favored Nations’ rule would set drug pricing for Medicare in line with the prices paid by other nations, where drugs can be much cheaper.
Analysts at BMO Capital Markets expect Summit and Akeso’s HARMONi-6 readout to put some pressure on Merck and its blockbuster biologic Keytruda.
Just raising the alarm won’t drive action. Use these three steps to turn insights into solutions that leadership can’t ignore.
Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.
Bausch Health has launched a shareholder rights plan—also known as a poison pill defense—designed to prevent any one entity from taking control of the company to the detriment of other shareholders.
Such a change would put the U.S. more in line with guidance in other countries and with the World Health Organization, which recommends one dose for children and adolescents only if they have comorbidities.
In December 2024, the FDA affirmed that the shortage of tirzepatide, marketed as Zepbound for weight loss, had ended, formally barring compounders from producing their knockoff versions of the drug.
FDA Commissioner Marty Makary talks about his plans to revamp drug development and reduce ‘conflicts of interest’ between the agency and pharma industry; Roche and Regeneron jump on the U.S. manufacturing train as Trump’s tariffs loom; and Eli Lilly scores a big win for orforglipron while Novo Nordisk reveals it has applied for FDA approval of its oral semaglutide.
Executives don’t just get paid big bucks to operate a company. Sometimes they get paid millions to walk away.