Drug Approval | October 04, 2021
Biocon launches Everolimus tablets in the US
According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021
According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
Acne affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago
The drug is also intended for the treatment of glioblastoma multiforme
This is Enzene Biosciences third biosimilar to be approved
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
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