Tag Archives: FDA

Sanofi and subsidiary Genzyme announced that FDA approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS)

Approval Establishes Genzyme’s MS Franchise in the U.S. with Two Approved Products; Follows Global Approvals PARIS, 17-11-2014 — /EuropaWire/ — Sanofi and its subsidiary Genzyme announced today that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for … Read the full press release

Sanofi: Genzyme’s Cerdelga™ capsules the only first-line oral therapy for certain adult Gaucher disease type 1 approved by FDA

Only First-Line Oral Treatment for Adult Gaucher Disease Type 1 Paris, 22-8-2014 — /EuropaWire/ — Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga™ (eliglustat) capsules, the only … Read the full press release

Nanostart-holding MagForce AG and its subsidiary in US held FDA meeting regarding MagForce’s NanoTherm® Therapy Pre-Submission

Frankfurt / Berlin, Germany and Nevada, USA, 5-5-2014 — /EuropaWire/ — Nanostart-holding MagForce, a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. are pleased to report that an in-person meeting was … Read the full press release

Sanofi halts clinical trials and plans for regulatory filings with its investigational JAK2 inhibitor fedratinib

Paris, France, 21-11-2013 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today the decision to halt all clinical trials and cancel plans for regulatory filings with its investigational JAK2 inhibitor, fedratinib (SAR302503). Following a thorough risk-benefit analysis, including consultation with the U.S. … Read the full press release

U.S. FDA’s Nonprescription Drugs Advisory Committee recommends approval of Sanofi’s Nasacort AQ Nasal Spray for over-the-counter use in the U.S.

Treats Seasonal and Year-round Nasal Allergy Symptoms in Adults and Children  Paris, France, 06-8-2013 — /EuropaWire/ — Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration’s (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted 10 to … Read the full press release

Novartis announced US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its serelaxin (RLX030) for acute heart failure

Recognition by the US Food and Drug Administration (FDA) that RLX030 has the potential to address a serious unmet medical need If approved, RLX030 has the potential to be the first treatment breakthrough for Acute Heart Failure patients in 20 … Read the full press release