Approvals
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.
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.
The FDA greenlit Reata Pharmaceuticals’ omaveloxolone (Skyclarys) as the first and only treatment for Friedreich’s ataxia, a rare, life-limiting neuromuscular disorder.
The hits kept coming for the sickle cell disease space last week as the FDA placed a full clinical hold on Fulcrum Therapeutics’ Investigational New Drug application FTX-6058.
The FDA approved Sanofi and Sweden-based Sobi’s efanesoctocog alfa, now marketed as Altuviiio, to treat bleeding in adults and children with hemophilia A.
There are currently no disease-modifying treatments for Friedreich’s ataxia. That could change when the FDA makes a decision about Reata Pharmaceuticals’ omaveloxolone on Feb. 28.
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