Baxalta Incorporated has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for approval of an investigational 20 percent concentration immunoglobulin subcutaneous treatment. Read More »
Pluristem Therapeutics Inc. on Wednesday announced it has completed a successful meeting with the U.S. Food and Drug Administration (FDA) about the start of a Phase I clinical trial for its PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation. Read More »
Supernus Pharmaceuticals Inc. on Tuesday received its fifth patent covering Oxtellar XR, its novel once-daily, extended-release oxcarbazepine product. Read More »
Titan Pharmaceuticals Inc. on Monday announced the resubmission by Braeburn Pharmaceuticals of a New Drug Application to the U.S. Food and Drug Administration for Probuphine. Read More »
Advaxis Inc. announced on Tuesday that its final clinical data from Stage 1 of the ongoing two-stage Phase 2 study of axalimogene filolisba in patients with persistent or recurrent metastatic carcinoma of the cervix will be presented at the American Gynecological & Obstetrical Society's annual meeting. Read More »
Sarepta Therapeutics Inc., a developer of RNA-targeted therapeutics, on Tuesday announced that the U.S. Food and Drug Administration (FDA) has filed the New Drug Application for eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. Read More »
Lannett Company said this week that its Silarx Pharmaceuticals subsidiary received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Aripiprazole 1 mg/mL Oral Solution, the generic version of the antidepressant drug ABILIFY. Read More »
iPhone app allows parents to customize the flavor of their child's medicine. Read More »
Sentrian said on Thursday that the Food and Drug Administration (FDA) has decided the company's Remote Patient Intelligence (RPI) mobile-health system meets the definition of a "medical device," on which the FDA intends to exercise "enforcement discretion." Read More »
The Food and Drug Administration last week approved a new cholesterol medication called Praluent, the first injection in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Read More »
The U.S. Food and Drug Administration late last week approved Praluent injections, the first cholesterol-lowering treatment cleared for use in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. Read More »
Hewitt W. "Ted" Matthews, longtime dean of Mercer University's College of Pharmacy, was recently presented with the Larry L. Braden Meritorious Service Award from the Georgia Pharmacy Association (GPhA). Read More »
The International Academy of Compounding Pharmacists (IACP) recently released its formal comments about its concerns over the proposed U.S. Food and Drug Administration (FDA) memorandum of understanding. Read More »
A new study shows that 80 percent of patients with cardiovascular disease drastically underuse statins, which shows that faithfully using statins continues to be an ongoing, long-standing, national concern in the U.S. Read More »
The Asthma and Allergy Foundation of America (AAFA) released results on Friday from a survey that indicated people with colds, coughs or allergies prefer full access to medications containing pseudoephedrine (PSE). Read More »
Epiduo Forte Gel, a new antibiotic-free treatment for acne from Galderma Laboratories, received approval from the U.S. Food and Drug Administration (FDA) on July 17. Read More »
Pharmacy Technician Educators Council honors ASHP director of special publishing. Read More »
According to an ASHP survey, pharmacists in hospitals across the U.S. are performing more medication-related patient transition of care interventions, 24/7 medication order review and patient medication counseling. Read More »
Gilead Sciences, Inc. said it submitted a new drug application to the U.S. Food and Drug Administration (FDA) on July 1 for an investigational, once-a-day single-tablet regimen for the treatment of HIV-1 infection in patients ages 12 and older. Read More »
Veloxis Pharmaceuticals A/S last week announced the U.S. Food and Drug Administration approved Envarsus XR for the prophylaxis of rejection in kidney transplant patients who require or want change from other twice-daily tacrolimus products to once-daily Envarsus XR. Read More »
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