A U.S. Food and Drug Administration (FDA) blog posted April 10 highlights the benefits of FDA collaborations in reducing the number of unapproved drugs while working to prevent drug shortages.  Read More »

Actavis confirmed last week that it has filed an abbreviated new drug application with the U.S. Food and Drug Administration (FDA), requesting approval to market Ambrisentan, and has confirmed a patent challenge. Read More »

The Food and Drug Administration (FDA) recently announced that fixed-combination drugs that are comprised of at least one new chemical entitity (NCE) will be eligible for five years of exclusivity. Read More »

The Food and Drug Administration (FDA) on Wednesday issued a final guidance to help the industry develop opioid drug products with potentially abuse-deterrent properties. Read More »

The American Society of Health-System Pharmacists (ASHP) said March 27 that 35 pharmacists who practice in hospitals, ambulatory care clinics and other settings have been named ASHP fellows. Read More »

In its 2011 report, the Government Accountability Office (GAO) found that the Health Resources and Services Administration’s (HRSA) oversight of the 340B Drug Pricing Program was insufficient to deliver an equitable guarantee that program participants were in compliance with program requirements. Read More »

A study published in the March issue of the journal Health Affairs suggests that most primary-care physicians are aware of prescription-drug monitoring programs, and that more physicians might use the programs if they were easier to use. Read More »

In the wake of the U.S. Food and Drug Administration's first biosimilar approval, the Alliance for Safe Biologic Medicines (ASBM) recently held a five-hour class to educate pharmacists on the fundamentals of these new medicines. Read More »

The National Association of Specialty Pharmacy (NASP) made an announcement Thursday that discussed the appointment of Jayson S. Slotnik as a health policy advisor and Virginia Sweeter to consultant for their meetings and education program. Read More »

Custom-compounded therapies unregulated by FDA. Read More »

The U.S. Food and Drug Administration (FDA) launched its first mobile app on Wednesday, which is designed to increase public access to important information on drug shortages. Read More »

The FDA's plan to let generic drug companies update their labels showed new signs of life this week. Read More »

The U.S. Food and Drug Administration released five new draft documents last week on compounding and repackaging to help commercial entities comply with important public health laws. Read More »

The U.S. Food and Drug Administration on Feb. 13 approved Lenvima (lenvatinib) to as a treatment for patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite radioactive iodine therapy. Read More »

Novartis said on Friday that the U.S. Food and Drug Administration (FDA) granted priority review designation to LCZ696, a test drug for the treatment of heart failure with reduced ejection fraction (HFrEF). Read More »

Cumberland Pharmaceuticals said on Wednesday that it is entering a Phase II development program for Boxaban (ifetroban), an oral capsule for the treatment of aspirin-exacerbated respiratory disease (AERD). Read More »

Amgen said on Wednesday that its Biologics License Application (BLA) for talimogene laherparepvec will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) and the Cellular, Tissue and Gene Therapies Advisory Committee. Read More »

TeaserMylan Inc. confirmed Monday that it and its subsidiary, Mylan Pharmaceuticals, have been sued by Onyx Pharmaceuticals, Bayer Healthcare LLC and Bayer Healthcare Pharmaceuticals Inc. in connection to an application to make a generic form of NEXAVAR. Read More »

Genentech, a member of the Roche group, said on Friday that the U.S. Food and Drug Administration (FDA) approved Lucentis, the first eye medicine sanctioned to treat diabetic retinopathy (DR) with diabetic macular edema (DME). Read More »

TissuGlu, the first tissue adhesive permitted for internal use, was approved Wednesday by the U.S. Read More »