The bill backed by Republicans decriminalizes cannabidiol, also known as CBD oil, if a patient has a doctor's prescription or is participating in a clinical trial for treating severe forms of epilepsy.
In anticipation of the March 13th deadline for comments on the FDA proposed rule on prescription...
The recall is being initiated as a result of complaints of particulate matter, identified as...
Pluristem Therapeutics today announced that the FDA has reviewed its PLacental eXpanded (PLX)...
Endo Pharmaceuticals has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone.
Eli Lilly and Boehringer-Ingelheim said that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.
Lifting of the clinical hold clears the company to proceed with the clinical development program in the US. The FDA communicated this information to the company during a conference call with the FDA on Friday, February 28, 2014
Teva Pharmaceutical has announced the approval of the generic equivalent to Evista® (Raloxifene) Tablets, 60 mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.
Forest Laboratories and Adamas Pharmaceuticals have jointly announced Forest’s submission of a New Drug Application (NDA) to the Food and Drug Administration for a fixed-dose combination (FDC) of memantine HCl extended release (ER) and donepezil HCl for the treatment of moderate to severe dementia of the Alzheimer’s type.
Stanford University is working with K-PAX Pharmaceuticals to perform a double-blind, placebo-controlled trial to evaluate the safety and efficacy of a currently available FDA-approved medication co-administered with a novel mitochondrial support product in order to identify a safe and effective treatment for the chronic fatigue and concentration disturbance symptoms.
Doctors and addiction experts urge the FDA to revoke approval of Zohydro.
AstraZeneca has announced that the FDA has approved the BYDUREON® Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Simulations Plus, Inc. announced that it has signed a research collaboration agreement with the FDA to determine the value of mechanistic absorption modeling (“MAM”) in developing predictive and robust in vitro-in vivo correlations (IVIVCs).
Naurex Inc. has announced that the FDA has granted Fast Track designation to the investigation of GLYX-13, the company's rapid-acting antidepressant in Phase 2 clinical development, as adjunctive therapy in major depressive disorder.
In a petition to the FDA, anti-addiction groups call the newly-approved drug Zohydro the next Oxycontin and they are warning if it is released to pharmacies as scheduled, it will also lead to more addiction and drug-related deaths.
Republican lawmakers blasted the Food and Drug Administration on Wednesday for secretly monitoring the emails of agency scientists who went public with allegations that they were pressured to approve certain medical devices.
People who take Januvia, Byetta or certain other widely prescribed medicines for diabetes can breathe a little easier — U.S. and European regulators have found no compelling evidence of a link between these drugs and pancreas problems or pancreatic cancer.
Several U.S. senators are co-sponsoring a bill that would curb electronic cigarette marketing while the fast-growing industry awaits federal regulation. The bill introduced Wednesday by California Sen. Barbara Boxer, Iowa Sen. Tom Harkin and others would ban marketing to children based on standards set by the Federal Trade Commission.
FDA is considering the new procedure that could give hope to women who can't have babies.
The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
Iroko Pharmaceuticals, LLC, has announced that the FDA has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults.
A consumer advocacy group is calling on the Food and Drug Administration to add a bold warning label to popular testosterone drugs for men in light of growing evidence that the hormone treatments can increase the risk of heart attack.
Federal health regulators will consider this week whether to green light a provocative new fertilization technique that could eventually create babies from the DNA of three people, with the goal of preventing mothers from passing on debilitating genetic diseases to their children.
Amarin Corporation has announced that the FDA has awarded three years of marketing exclusivity to Vascepa(R) (icosapent ethyl) capsule. FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.
The head of the Food and Drug Administration says her agency will add more inspectors in India to better monitor drugs from the country's burgeoning pharmaceutical industry, even as her agency also seeks closer cooperation with Indian regulators.
Vertex Pharmaceuticals today announced the FDA approved a supplemental New Drug Application (sNDA) for KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The Food and Drug Administration is seeking to revamp its system for regulating hundreds of over-the-counter drugs, saying the decades-old process is not flexible enough to keep pace with modern medical developments. In a federal posting Friday, the agency announced a two-day meeting next month to discuss overhauling the system known as the over-the-counter monograph.
Med-Vet International initiated a nationwide recall of 140 boxes of 1/2cc U-40 insulin syringes. The syringes have been found to be labeled with 40 units per 1/2cc syringe and they should be marked with only 20 units per 1/2cc, which potentially could result in lower than prescribed doses of insulin.
Pluristem Therapeutics, Inc., today announced it is submitting its application to the FDA requesting the company be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.
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