Selpercatinib FDA approval : Lilly’s therapy approved for treatment of lung and thyroid cancers with RET alteration

pharmanewsdaily- May 9, 2020 0

Selpercatinib FDA approval : The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Retevmo (selpercatinib) capsules for the treatment of three ... Read More

FDA grants EUA for Gilead’s investigational COVID-19 drug remdesivir

pharmanewsdaily- May 4, 2020 0

Remdesivir EUA status : The US has officially pushed the use of remdesivir for treating the novel coronavirus with the Food and Drug Administration (FDA) ... Read More

GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status

pharmanewsdaily- April 26, 2020 0

COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time ... Read More

Actemra coronavirus clinical trial : Genentech gets FDA nod for COVID-19 trial

pharmanewsdaily- March 24, 2020 0

Actemra coronavirus clinical trial : Genentech has been given approval by the US Food & Drug Administration (FDA) to undertake the phase 3 COVACTA trial ... Read More

Gilead Sciences bags Epclusa FDA approval for hepatitis C in pediatric patients

pharmanewsdaily- March 20, 2020 0

Epclusa FDA approval : Gilead Sciences has secured an expanded approval for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) from the US Food and ... Read More

F2G’s olorofim gets FDA ODD for mold infections and Valley Fever

pharmanewsdaily- March 12, 2020 0

F2G has bagged orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for olorofim (formerly F901318) for the treatments of invasive mold ... Read More

FDA approves Opdivo + Yervoy for HCC previously treated with sorafenib

pharmanewsdaily- March 12, 2020 0

Bristol Myers Squibb has secured approval for the combination of Opdivo (nivolumab) 1 mg/kg and Yervoy (ipilimumab) 3 mg/kg from the US Food and Drug ... Read More

Olympus secures FDA clearance for TJF-Q190V duodenoscope

pharmanewsdaily- February 9, 2020 0

Olympus Medical Systems Group has secured clearance from the US Food and Drug Administration (FDA) for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. ... Read More

Aimmune Therapeutics bags Palforzia FDA approval for peanut allergy

pharmanewsdaily- February 3, 2020 0

Palforzia FDA approval : Aimmune Therapeutics has been granted approval from the US Food and Drug Administration (FDA) for Palforzia for the treatment of peanut ... Read More

LIAISON QFT-Plus automated screening solution gets FDA nod for TB detection

pharmanewsdaily- January 1, 2020 0

Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) to use QuantiFERON-TB Plus (QFT-Plus automated screening solution) on the latter’s ... Read More