Oraya Therapeutics announced that initial three-year safety follow-up data from its INTREPID study of Oraya Therapy stereotactic radiotherapy for the treatment of wet age-related macular degeneration (AMD) were presented for the first time ...
Tags: Oraya Therapeutics, Medicine
Cartiva, a developer of products for the treatment of cartilage injuries and osteoarthritis, has signed an exclusive distribution agreement with Rehab Matrix Canada, a distributor of foot and ankle orthopedic medical devices. Pursuant to ...
Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over. The MAA is based on results ...
The US Food and Drug Administration (FDA) has approved Sunovion Pharmaceuticals' (Sunovion) antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in patients with epilepsy. According to the ...
Tags: FDA, Sunovion, partial-onset seizure, epilepsy
UK-based GlaxoSmithKline (GSK) and US-based Theravance have announced the availability of BREO ELLIPTA, a once-daily prescription medicine for chronic obstructive pulmonary disease (COPD), in the US pharmacies. BREO ELLIPTA is a ...
US-based Boston Scientific has obtained CE Mark approval for its Lotus valve system, a transcatheter aortic valve replacement (TAVR) device designed to treat patients with severe aortic stenosis who are at high risk with surgical valve ...
Tags: Lotus Valve System, Health, Medicine
Lundbeck, a Denmark-based pharmaceutical company, has obtained the US Food and Drug Administration (FDA) approval for its SABRIL (vigabatrin), an adjunctive treatment option for children 10 and older with refractory complex partial ...
Cervel Neurotech has initiated a clinical study for patients suffering from treatment resistant depression at seven leading academic and research centers in the US. The 80-patient trial, designed as a randomized, sham-controlled, double ...
Boehringer Ingelheim has obtained marketing approval for Striverdi Respimat (olodaterol), a long-lasting bronchodilator indicated for chronic obstructive pulmonary disease (COPD), in the UK, Denmark and Iceland. This approval is based ...
AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
US-based Pulsar Vascular has obtained CE Mark approval for its PulseRider device, designed to bridge the neck of cerebral aneurysms previously not amenable to endovascular therapy. With this CE Mark approval, the company now has full ...
Tags: Pulsar Vascular, CE Mark Approval
US-based medical device company Moximed has announced the successful completion of 500th worldwide implant of its KineSpring system, intended to provide a new treatment option for patients with mild-to-moderate knee osteoarthritis. The ...
Tags: Kinespring System, medical device
Integra LifeSciences, an integrated medical technology company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Integra laminoplasty system, a comprehensive set of implants and instruments designed for ...
Cornerstone Pharmaceuticals has received the US Food and Drug Administration (FDA) orphan drug designation for its altered energy metabolism directed (AEMD) drug candidate 'CPI-613' for treatment of myelodysplastic syndrome (MDS). MDS is ...
Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals International subsidiary Valeant Canada's new drug submission of Jublia for the treatment of onychomycosis. Jublia is designated for the treatment of mild to ...
Tags: Fungal Drug, Medicine