Astellas Pharma has gained FDA approval for Myrbetriq (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. Myrbetriq is a once ...
Tags: FDA approval, pharmaceutical product, oral OAB treatment
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension ...
Tags: FDA approval, pharmaceutical product, generic antitussive product
Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA. Cabozantinib is ...
Tags: submission of new drug application, FDA, pharmaceutical product
Cipher Pharmaceuticals, a specialty pharmaceutical company, has received FDA approval for Absorica for the treatment of severe recalcitrant nodular acne. The company expects to launch its patented brand formulation of the acne ...
Medivation and Astellas Pharma have announced the submission of new drug application (NDA) for enzalutamide (formerly MDV3100) to the FDA. The enzalutamide has been studied in patients with castration-resistant prostate cancer who ...
Tags: enzalutamide, new drug application, pharmaceutical product
Watson Pharmaceuticals has confirmed the filing of ANDA with FDA by Watson Laboratories seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets, 1mg/0.01mg and 0.01mg and 75mg. ...
Tags: pharmaceutical product, pregnancy prevention drug, FDA
The FDA has granted fast track designation for Achillion Pharmaceuticals' ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor ...
Tags: FDA Fast Track Designation, chronic hepatitis C, pharmaceutical product
Ohr Pharmaceutical has gained US and European patients entitled, preparation of a therapeutic composition. The patents cover claims related to the chemical structures, sequences of the peptide constituents and method of manufacture of ...
Tags: patent, cancer cachexia program, pharmaceutical product
The European Commission (EC) has awarded a conditional marketing authorization approval for Cell Therapeutics' Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive ...
Tags: marketing authorization, pharmaceutical product, Pixuvri
Vivus has received NDA approval for TA-1790 (avanafil), indicated for the treatment of erectile dysfunction (ED), in the US. VIvus will market the product under the brand name Stendra in the US. Mitsubishi Tanabe Pharma has ...
Tags: avanafil, erectile dysfunction, pharmaceutical product
Pain Therapeutics, a biopharmaceutical company, has received four US patents covering Remoxy (oxycodone) extended-release capsules CII. The issued patents are licensed exclusively to Pain Therapeutics in the US and international ...
Tags: Patent, extended-release capsule, pharmaceutical product
Dynavax Technologies has submitted a US Biologics License Application (BLA) to the FDA for HEPLISAV, an investigational adult hepatitis B vaccine. In Phase III trials, HEPLISAV demonstrated higher and earlier protection with fewer ...
SK Biopharmaceuticals, a South Korean pharmaceutical company, has received orphan drug designation status for carisbamate for the management of patients with infantile spasms (IS). Carisbamate has previously been shown to have ...
Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC). The filing was based on the Phase III ...
Newron Pharmaceuticals has signed a strategic collaboration and licence agreement with Zambon Company for Safinamide in the EU and US. As per the agreement, Zambon will initially invest €20m into Newron, covering the completion ...
Tags: collaboration, pharmaceutical product, clinical development, Safinamide