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/ —…

10 years ago

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…

10 years ago

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…

10 years ago

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…

10 years ago

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…

11 years ago

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…

11 years ago
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