Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
FEATURED STORIES
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Incyte Corporation reported that the FDA has pushed back the review of the company’s supplemental New Drug Application (sNDA) for Opzelura (ruxolitinib cream) for vitiligo.
In the latest results shared by the company, treatment with nusinersen for a median of 4.9 years helped participants maintain and make progressive gains in motor function.
Shares of Sanofi took a hit in premarket trading after it announced its Phase II breast cancer study assessing an experimental oral SERD failed to hit the mark.
Pfizer will cease operations within Russia and proceeds from its subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine.
A new study out of Duke University added weight to the determination that asthma in children did not increase infection risk, children slow to get COVID vaccine and more COVID-19 news.
The U.S. FDA has approved Lynparza for the adjuvant treatment of patients diagnosed with germline BRCA-mutated HER2-negative high-risk early breast cancer.
Novartis released new data Monday from its Phase III SPR1NT trial that reinforces the benefits of Zolgensma.
This week is starting off strong with some positive clinical news from Ascendis Pharma, Can-Fite and BridgeBio.
AstraZeneca’s Fasenra hit a roadblock after the FDA issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Bristol Myers Squibb and Nektar Therapeutics said their joint Phase III PIVOT IO-001 study did not meet two endpoints: progression-free survival and objective response rate.