Approvals
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
Wednesday, the FDA approved Cidara Therapeutics and Melinta Therapeutics’ Rezzayo (rezafungin) injection to treat candidemia and invasive candidiasis.
BioNTech inked an exclusive worldwide license and collaboration agreement with OncoC4 to develop and commercialize its investigational anti-CTLA-4 antibody ONC-392 for solid tumors.
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
The FDA has one target action date and one advisory committee meeting scheduled for this week. It is also gearing up for an adcomm that could prove to be pivotal for neurodegenerative diseases.
The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.
Three years after the FDA rejected its initial biologic license application, Mesoblast announced its resubmission for Ryoncil. Now, the treatment is getting a second chance.
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