FDA approval

Sanofi’s Dupixent Receives FDA Approval for Pediatric Eosinophilic Esophagitis (EoE) Treatment

(IN BRIEF) The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) to treat pediatric patients aged…

3 months ago

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application…

4 months ago

AstraZeneca’s FluMist Nasal Spray Moves Closer to FDA Approval for Self-Administration

(IN BRIEF) AstraZeneca's Supplemental Biologics License Application (sBLA) seeking approval for a self- or caregiver-administered option for FluMist Quadrivalent, a…

6 months ago

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…

7 years ago

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…

8 years ago

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…

9 years ago

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…

9 years ago

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…

10 years ago