Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application for Vancomycin hydrochloride capsules, USP, 125mg and 250mg. The company has begun the shipment of the product ...
The US Food and Drug Administration (FDA) has announced that it is requesting a budget of $4.7bn in 2014, which includes about $295.8m to strengthen food safety. The agency noted that the user fees would fund 94% of the proposed budget ...
Tags: FDA, Food Safety
Neuralstem has obtained notice of allowance for a patent that covers various methods to use expanded spinal cord stem cells such as NSI-566 to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The company completed Phase ...
Agilent Technologies' company, Dako, has announced that US Food and Drug Administration (FDA) has given consent to sell its Clone EP1 diagnostic tool for breast cancer treatment in the US market. The antibody, called FLEX Monoclonal ...
GlaxoSmithKline (GSK) has received the marketing authorization from Germany's Paul Ehrlich Institut (PEI) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for its quadrivalent (four-strain) influenza vaccine. ...
Tags: GSK, Strain Influenza Vaccine
US-based Rich Products is expanding its voluntary recall of frozen snack foods produced at its Waycross, Georgia facility as they may be contaminated with E. coli O121 bacteria. On 28 March, the New York-based firm issued a voluntary ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to CryoLife's new Hemodialysis Reliable Outflow (HeRO) device. The device, which the company claims, is the only subcutaneous AV access solution that maintains ...
Biotechnology company Genmab has obtained FDA fast track designation in double refractory multiple myeloma for daratumumab. As per the designation, the human CD38 monoclonal antibody Daratumumab is suitable for multiple myeloma patients ...
The US Food and Drug Administration (FDA) has cleared Hitachi Medical Systems America's new SCENARIA scalable CT platform. The new SCENARIA Advanced 128 CT system, which combines the latest dose saving and imaging technologies, ...
Tags: FDA, Hitachi Medical, Medicine
The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%. Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International. Mylan ...
Tags: FDA, Acyclovir Ointment, Medicine
Canada-based biotechnology company Kane Biotech announced that DispersinB-Gentamicin combination wound gel spray has passed the primary skin irritation tests. The test was aimed at determining the dermal irritation potential of the spray ...
Tags: Dispersinb Combination, Skin Irritation Tests, Medicine
The US Food and Drug Administration (FDA) has recommended removing certain warning statements and modifications of the instructions for the use of over-the-counter (OTC) nicotine replacement therapy (NRT) products. Commending FDA ...
Tags: FDA, Nicotine Medications Labeling, Medicine
One of the lesser-known tasks for U.S. Customs officials is confiscating chocolate "surprise eggs" from travelers. More than 60,000 surprise eggs are seized at the U.S. border each year with penalties up to $2,500 per egg. Brands such as ...
US-based medical technology company Medtronic has secured US marketing rights for its Affinity Fusion oxygenation system following the regulatory approval from the US Food and Drug Administration (FDA). The CE-marked system, which serves ...
Tags: FDA, Fusion Oxygenation System
India-based Dr. Reddy's Laboratories has announced the launch of Zenatane (Isotretinoin Capsules USP) in 20mg and 40mg strengths in the US. The launch follows the FDA approval of the company's ANDA for Zenatane 10mg, 20mg and 40mg. ...
Tags: Zenatane, FDA, Isotretinoin Capsules