Integrase inhibitors

EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

Antibiotics, Birth Defects, Blockbusters, Bones, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, FDA/Regulatory, Fluoroquinolones, Integrase inhibitors, Muscles, Nervous System, Pharmacovigilance Risk Assessment Committee (PRAC), Quinolone, Tendons

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

October 5, 2018/by Reuters Health

U.S. FDA approves Gilead triple HIV drug

Approvals, Biotech, Black Box Warning, FDA, FDA/Regulatory, HIV, Integrase inhibitors, Nucleoside Reverse Transcriptase Inhibitors, Patent Infringement, Potential Blockbusters, Pricing

The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.

February 7, 2018/by Reuters Health

U.S. FDA approves first two-drug HIV regimen in win for GSK

"Closed Triple" Therapies, Approvals, FDA, FDA/Regulatory, HIV/AIDS, Integrase inhibitors

The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.

November 21, 2017/by Reuters Health