Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay ...
The FDA's recent approval of Zarxio, the first biosimilar product approved in the United States...
The FDA wants to know how patient perceptions of medications change when pharmacies switch from...
Today, Rhodes Pharmaceuticals L.P. announced that Aptensio XR, a once-daily central nervous...
The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.
There’s a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.
Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes.
Treatment results with the breast cancer drug Herceptin, as well as chemotherapy, did improve, but the drug's backers had been hoping to see better results.
Colombian President Santos last week decided to halt fumigation in the wake of a report by a research arm of the World Health Organization classifying (anti-coca) glyphosate as a probable carcinogen.
Federal health advisers recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients.
The FDA has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator for the prevention of oral mucositis.
The Food and Drug Administration said in an online review that the benefit was small and it is unclear if the addition of a second drug ingredient adds to the pill's effectiveness.
Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets.
Teva announced a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter.
Dow Development Laboratories in California is working to position itself as the "go-to" contract manufacturer for topical product development services.
The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.
Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine in treating coughs and upper respiratory allergies.
GW Pharmaceuticals Receives Orphan Drug Designation For Cannabidiol Treatment of Neonatal Hypoxic-Ischemic EncephalopathyApril 24, 2015 11:15 am | by Globe Newswire | News | Comments
There are currently no FDA-approved medicines specifically indicated for NHIE.
Hospira is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial.
Capricor Therapeutics, Inc. today announced that it has been granted orphan drug designation by FDA for its cell therapeutic product candidate, CAP-1002, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).
The company alerted U.S. customers Tuesday that the vaccine can lose potency and fail to adequately protect against some strains of the flu.
More than half of the older adults in the United States are now taking a daily dose of aspirin, even though its use is not recommended by the Food and Drug Administration for most people who have not yet had a heart attack or stroke.
The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).
Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.
OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.
The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage.
IDT Australia Limited announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT.
The issue also intensified criticisms of the FDA.
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