Baxalta Inc., a worldwide leader in pharmaceuticals committed to developing therapies to combat orphan diseases, has announced the submission of supplemental Biologics License Applications (sBLAs) for the approval of ADYNOVATE by the U.S. Food and Drug Administration (FDA). Read More »
Allegran announced this week that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for AVYCAZ and has granted the sNDA priority review status. Read More »
Endo Pharmaceuticals Inc. announced this week that BELBUCA buccal film is now available. Read More »
The National Association of Chain Drug Stores (NACDS) has continued its discussions with congressional stakeholders after the release of the Covered Outpatient Drugs Final Rule by the Centers for Medicare & Medicaid Services (CMS), which would alter significantly reimbursement by pharmacies for both generic and brand name drugs distributed to Medicaid users. Read More »
The U.S. Food and Drug Administration (FDA) has put out an alert to health care professionals about the recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride. Read More »
The U.S. Food and Drug Administration (FDA) announced this week that Briviact (brivaracetam) has been approved as a treatment of epileptic seizures by being added on to other medications. Read More »
AstraZeneca and its research and development subsidiary, MedImmune, announced this week that the United States Food and Drug Administration (FDA) has granted durvalumab (MEDI4736) Breakthrough Therapy designation (BTD). Read More »
Renewed calls for a federal ban on prescription drug advertising to consumers needs to be squashed immediately, the Association of National Advertisers (ANA) says. Read More »
At Congress’ first oversight hearing since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) held last week, Chip Davis, president and CEO of Generic Pharmaceutical Association (GPhA), called for safe and effective biosimilars. Read More »
The American Society of Health-System Pharmacists (ASHP) praised the White House's proposal last week of putting $1.1 billion in federal money toward preventing prescription opioid abuse and heroin use. Read More »
The American Society of Health System Pharmacists (ASHP) has formally announced that it has joined the alliance for the Campaign for Sustainable Rx Pricing (CSRxP). Read More »
The American Society of Health-System Pharmacists (ASHP) and the American Pharmacists Association (APhA) have agreed on a new archetype for PGY1 Community-based Pharmacy Residency Programs. Read More »
The American Society of Health-System Pharmacists (ASHP) recently released its 2016 edition of the AHFS Drug Information (AHFS DI). Read More »
The U.S. Food and Drug Administration (FDA) has made a commitment to work on the backlogged list of generic drugs currently awaiting approval. Read More »
AstraZeneca announced this week that its product Lynparza has been granted Breakthrough Therapy designation (BTD) by the U.S. Food and Drug Administration (FDA). Read More »
The ASHP has published a new guide that will help determine the proper doses of medication for obese patients. Read More »
The Centers for Medicare and Medicaid Services (CMS) confirmed last week a rule to restructure Medicaid rebate and reimbursement programs for prescription drugs. Read More »
Allegran has announced that the Food and Drug Administration (FDA) has approved Botox to treat lower limb spasticity in adults. Read More »
Maryland policymakers should "tread lightly" when considering whether or not to regulate pharmacy benefit managers (PBMs), said Marc Kilmer, senior fellow for the Maryland Public Policy Institute (MPPI). Read More »
The Medicare Payment Advisory Commission (MedPAC) has recommended to Congress that Medicare payments made to safety net hospitals be cut by 10 percent based on the 340B drug discount program. Read More »
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