Bedford Laboratories has issued a nationwide voluntary hospital/user-level recall of certain lots of leucovorin calcium injection due to the discovery of visible crystalline particulate matter in a small number of vials. The particulate ...
Bedford Laboratories has issued hospital/user-level voluntarily recall of Vecuronium Bromide for Injection preservative free, Lot 2067134, because of possible health risk. The voluntary recall is being conducted due to the discovery of ...
Astellas Pharma and AstraZeneca have announced the approval of the dry-power inhaler Symbicort Turbuhaler for the additional indication of chronic obstructive pulmonary disease(COPD). Symbicort Turbuhaler is a combination product ...
Tags: Astellas Pharma, AstraZeneca, dry-power inhaler Symbicort Turbuhaler
HTG Molecular Diagnostics has gained rights to commercialize the Centre of Excellence for the Prevention of Organ Failure's(PROOF Centre)-developed gene expression blood tests,following the finalization of the license agreement. The gene ...
Tags: HTG Molecular Diagnostics, Prevention of Organ Failure, COPD, qNPA
The US Food and Drug Administration(FDA)has granted orphan drug designation to Savara Pharmaceuticals'first inhaled antibiotic,designed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus(MRSA)infection in cystic ...
Tags: Orphan Drug, Savara Pharma, FDA, inhaled antibiotic, MRSA
The US Food and Drug Administration(FDA)approved Actelion Pharmaceuticals'supplemental new drug application(sNDA)for second generation Veletri(epoprostenol)for injection. Veletri(epoprostenol)for injection is indicated for the treatment ...
Tags: FDA, Actelion sNDA, Actelion Pharmaceuticals, Veletri
GeNO has received two new US patents for its proprietary nitric oxide(NO)generation and delivery technology. The US patent no.8,173,072 describes the conversion of nitrogen dioxide(NO2)to nitric oxide(NO),using the GeNO cartridge ...
Tags: nitric oxide(NO)generation, nitric oxide(NO)delivery, US Patents, GeNO
Pulmatrix has announced the results of a clinical study showing that an iCALM (inhaled cationic airway lining modulator therapy) attenuated allergen-induced bronchitis in susceptible asthmatic patients. The study concluded that iCALM is a ...
The US Food and Drug Administration (FDA) has accepted GeNO's filing of new drug application (NDA) for GeNOsyl MVG-2000 nitric oxide delivery system. GeNOsyl nitric oxide is a vasodilator which is indicated for the treatment of term and ...
Tags: GeNOsyl nitric oxide, FDA
United Therapeutics has received complete response letter (CRL) from the FDA for an oral formulation of Remodulin (treprostinil). Treprostinil is indicated for pulmonary arterial hypertension (PAH) that is at present available in ...
Tags: Medicine, Treprostinil
Pulmatrix, a developer of inhalable drug delivery platforms, has appointed Robert Clarke as the company's new chief executive officer (CEO). Previously, Clarke served as the company's chief scientific officer and vice president of ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to GeNO for use of inhaled nitric oxide (NO) in treatment of persistant pulmonary hypertension of the newborn (PPHN). The orphan drug designation was granted ...
Tags: orphan drug designation, FDA, persistant pulmonary hypertension
Aptar Pharma, a manufacturer of nasal and pulmonary drug delivery devices, has launched Twister, a new capsule-based Dry Powder Inhaler (DPI) for asthma sufferers. Twister is a transparent device that operates by three simple steps: ...
Tags: Aptar Pharma, drug delivery devices, DPI
Crux Biomedical has obtained the US Food and Drug Administration (FDA) approval for its bi-directional retrieval inferior vena cava filter (VCF), designed to trap blood clots leading to fatal pulmonary embolisms. The helical shape of VCF ...
Tags: Crux Biomedical, vena cava filter, VCF
GlaxoSmithKline (GSK) and Theravance have announced the regulatory submissions for furoate FF/vilanterol VI (FF/VI) to treat chronic obstructive pulmonary disease (COPD) in the US and Europe. The companies also announced regulatory ...