Category: Approval

March 14, 2017 Off

FDA OK’s Novartis’s breast cancer drug

By Dino Mustafić

The US Food and Drug Administration (FDA) has approved Novartis’s Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

March 13, 2017 Off

Biotechnology companies stocks report

By Dino Mustafić

iShares NASDAQ Biotechnology exchange-traded fund has gained 13% so far this year, more than double the SPDR S&P 500 ETF’s 6.3% rise, as the potential for new drugs and mergers and acquisitions has rekindled interest in the beaten-down sector.

March 13, 2017 Off

Ipsen wins MHRA’s approval for its breast cancer drug

By Dino Mustafić

Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved a new indication for Ipsen’s Decapeptyl as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in women at high-risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.