Phase III
The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.
Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.
Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
Today, Astellas announced that after evaluating its gene therapy for patients with X-linked Myotubular Myopathy, it revised its eligible treatment population and any likely future product label.
It was yet another busy week for clinical trial news, with a range of studies for COVID-19, various cancers, fungal infections and other indications.
Bayer has lured another top oncology expert from GlaxoSmithKline. Tara Frenkl is joining the Germany-based life sciences giant as the new head of oncology development.
Long COVID is loosely defined as COVID-19 symptoms that persist for longer than four weeks from an initial diagnosis. Here’s a look at the latest in long COVID research.
Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
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