Drug Approval | August 12, 2021
Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
It’s an AB-rated generic therapeutic version of Durezol
It’s an AB-rated generic therapeutic version of Durezol
SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial
The company is eligible for 12 months exclusivity from launch
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
If approved it will bring a second source of MMR vaccine to the US market
Nearly 6,000 patients have been treated with the drug since 2017
Deal signed with AOP Orphan for US commercial rights
QIAreach SARS-CoV-2 antigen test, developed in collaboration with Ellume, is easy to use and provides accurate and objective results in 2 to 15 minutes
The product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients
Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells
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