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New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Read our takes on the biggest stories happening in the industry.
Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due to resource constraints and reports surfaced that Commissioner Marty Makary tried to have the application rejected.
Despite rehiring hundreds of FDA, CDC and NIH employees, the Department of Health and Human Services is still a skeleton of its former self under Health Secretary Robert F. Kennedy Jr.
TIGIT-targeting therapies have largely disappointed in recent months, with failed studies, terminated partnerships and shuttered businesses. Here are five biopharma players staying alive with differentiated candidates against the once promising immuno-oncology target.
Slashing adverse drug reactions through pharmacogenetics and advanced AI could help rehabilitate the pharmaceutical industry’s reputation amid mounting criticism.
After the FDA rejection of Zurzuvae in one type of depression and the triple failure of neuro asset dalzanemdor, Sage was searching for a path forward at the end of December 2024. Biogen CEO Chris Viehbacher spied a possible deal, but the smaller company wasn’t interested.
Bioinformatics is on the rise, forecasted to grow by about $16 billion from 2024 to 2029 given its value to managing mass datasets critical to modern drug discovery and development. Two talent acquisition experts share how the field has evolved in the past few years and which skills are most in demand.
Novartis is falling farther behind AbbVie, which expanded its JAK inhibitor Rinvoq into giant cell arteritis in April.
Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease.
While it trails Johnson & Johnson’s Tecvayli, Regeneron still hopes Lynozyfic can differentiate in terms of dosing convenience and efficacy.
An open letter signed by more than 50 industry executives blasts a “fundamentally, fatally flawed” report that urges greater restrictions on the abortion pill.