Tag Archives: FDA approval

AstraZeneca announce FDA approval of once-daily Qtern for the treatment of type-2 diabetes

Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level LONDON, 03-Mar-2017 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg … Read the full press release

Medtronic’s IN.PACT Admiral drug-coated balloon treatment for in-stent restenosis receives FDA approval

IN.PACT Admiral DCB Indication Expansion to Treat Patients with ISR DUBLIN, 16-Sep-2016 — /EuropaWire/ — Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) as a treatment for in-stent … Read the full press release

FDA approval for Roche’s cobas® HBV and cobas® HCV viral load tests

cobas 6800/8800 Systems offer fastest time to results and highest throughput of any molecular platform, helping to improve disease management and patient care BASEL, 19-10-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received … Read the full press release

Novartis’s Signifor® LAR to treat patients with life-threatening hormonal disorder acromegaly receives FDA approval

Acromegaly is an endocrine disorder caused by elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels[1] Signifor LAR, a next-generation somatostatin analog, provides a new option for patients with acromegaly with inadequately controlled disease[2] Signifor LAR FDA approval is … Read the full press release

Roche’s cobas HPV Test for first-line primary screening test for cervical cancer gets FDA approval

Expanded indication makes cobas HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older Basel, 29-4-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that … Read the full press release