Novartis has won FDA approval for Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after ...
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
Baxter International has received the US Food and Drug Administration (FDA) approval for its 4000 IU dosage strength of Advate[Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method]. Advate is a full-length recombinant factor ...
Tags: FDA, Baxter hemophilia drug, dosage strength
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 ...
Bristol-Myers Squibb (BMY) and Eli Lilly (LLY) have received an approval from US Food and Drug Administration (FDA) to expand the use of Erbitux in combination with the chemotherapy regimen Folfiri as an initial treatment of patients with ...
Tags: FDA approval, Erbitux, KRAS mutation-negative colorectal cancer
Cornerstone Therapeutics has acquired a privately-held specialty pharmaceutical company focused on the acute-care hospital setting, EKR Therapeutics. As part of the merger, Cornerstone will assume the responsibility to market and promote ...
Tags: Cornerstone Therapeutics
Actavis Group has gained FDA approval to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII (Mixed Amphetamine Salts ER Capsules). The Mixed ...
Tags: FDA, Actavis Group, Amphetamine
The US Food and Drug Administration (FDA) has approved Pfizer's Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury based on priority review. The FDA approval is based on two ...
Tags: FDA approval, neuropathic pain, Lyrica, clinical researh
Watson Pharmaceuticals said Sunovion Pharmaceuticals has challenged Watson Laboratories filing of Abbreviated New Drug Application(ANDA)with the US Food and Drug Administration(FDA)seeking approval for marketing Levalbuterol Tartrate ...
Tags: Sunovion, FDA, Watson Laboratories
Dako, a Danish provider of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and HER2 FISH pharmDx Kit as companion diagnostics for pertuzumab (Perjeta) - a new Genentech ...
Tags: Dako, cancer diagnostics solutions, HercepTest, HER2 FISH
The US Food and Drug Administration (FDA) has approved Genentech's Perjeta (pertuzumab) for the treatment of HER2-positive metastatic breast cancer (mBC), in combination with Herceptin (trastuzumab) and docetaxel chemotherapy. The ...
Tags: FDA approval, breast cancer, clinical study, pharmaceutical product
Lupin Pharmaceuticals has received FDA approval for Suprax (Cefixime) capsules 400mg and will initiate the shipment of the product shortly. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved ...
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
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 ...