The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients
The company does not expect the outcome of this inspection to impact its plans
The company plans to launch its exclusive e-pharmacy and telemedicine services in India by December 2021
The company is the Clinical Research Organisation of Caplin Point Laboratories
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
The company said in a regulatory filing that it was confident of addressing the observations satisfactorily
Initiation of EBT-101 Phase 1/2 clinical trial expected later this year
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care
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