Pfizer's rheumatoid arthritis treatment, tofacitinib, has obtained approval in several additional countries globally, including Switzerland, Argentina, Kuwait, UAE and Russia for patients with inadequate response to current therapies. The ...
CryoLife has received premarket approval from the US Food and Drug Administration (FDA) for its new Sologrip, a minimally invasive laser fiber-optic delivery system. The Sologrip delivery system is a single-use, disposable handset ...
Cipher Pharmaceuticals has launched Epuris (isotretinoin) capsules for the treatment of severe acne in patients aged 12 years and more in Canada. Available in 10mg, 20mg, 30mg, and 40mg oral capsules, the novel brand formulation of the ...
Tags: Epuris capsules, Medicine
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
The US Food and Drug Administration (FDA) has given its clearance to Amgen's XGEVA (denosumab) to treat adult or skeletally mature patients suffering from giant cell tumor of bone (GCTB). Approved after conducting a priority review, XGEVA ...
Tags: Amgen's XGEVA, Medicine
Eisai has announced the availability of Belviq (lorcaserin HCl) CIV tablets in the US, which is designed for chronic weight management in adults who are overweight with a comorbidity or obesity. Indicated for people with body mass ...
Tags: Eisai, Weight Management Therapy
Takeda Pharmaceutical Company, AMAG Pharmaceuticals' European commercial partner, has submitted a type-II variation to the European Medicines Agency (EMA) for label expansion of Rienso (ferumoxytol). The approval will allow the use of ...
Tags: Takeda, EMA Approval
Proton therapy systems developer Mevion Medical has delivered the superconducting synchrocyclotron accelerator for its Mevion S250, which is presently under installation at the Peggy and Charles Stephenson Cancer Center at the University of ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Celgene International's oral anti-cancer therapy Pomalidomide. The positive results from the MM-003 study of ...
Medtronic has completed randomizing Symplicity HTN-3, a clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension. Renal denervation is a minimally invasive, catheter-based procedure that decreases the ...
Tags: Medtronic, Randomizing Symplicity
Duchesnay USA has announced the availability of Diclegis, a composition of 10mg doxylamine succinate and 10mg pyridoxine hydrochloride (vitamin B6), in US pharmacies. The FDA had approved Diclegis as the only treatment for nausea and ...
Tags: Duchesnay USA, Diclegis
US-based medical device company St Jude Medical has commenced its EnligHTNment clinical study. The EnligHTNment study will assess whether the EnligHTN Multi-Electrode Renal Denervation System can minimize the risk of major cardiovascular ...
Tags: St Jude Medical, Clinical Study
Ablynx has commenced pre-clinical development of ALX-0962, an anti- immunoglobulin E (IgE) nanobody, to treat severe allergic asthma and expects to begin Phase I development in the second half of 2014. ALX-0962 comprises anti-IgE Nanobody ...
Tags: Ablynx, Pre-Clinical Development
Merck, referred to as MSD outside the US and Canada, has obtained FDA approval for Liptruzet tablets as an adjunctive therapy to diet for the treatment of elevated low-density lipoprotein (LDL) cholesterol in primary or mixed hyperlipidemia ...
Tags: Merck, Liptruzet Tablets
Forest Laboratories and Almirall have reported positive results from the ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD (ACLIFORM/COPD) Phase III study. ACLIFORM/COPD is the ...