Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Read More »

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Read More »

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). Read More »

The U.S. Food and Drug Administration approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Read More »

New grants support FDA’s GDUFA priorities of expanding bioequivalence methods for topical dermatological products and improving PBPK models of drug absorption via complex delivery routes Read More »

Arixa Pharmaceuticals issued the following announcement on Nov. 12.Arixa Pharmaceuticals™, Inc., a company dedicated to developing oral antibiotics for drug-resistant Gram-negative infections, today announced publication of a paper describing the chemistry of its oral prodrug of avibactam, a previously intravenous (IV)-only beta lactamase inhibitor (BLI). Read More »

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Read More »

Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") announced the sale of its proprietary antibiotic, VIBATIV® (telavancin), to Cumberland Pharmaceuticals, Inc. Read More »

AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced the approval of DSUVIA™ by the U.S. Food and Drug Administration (FDA). Read More »

LORBRENA Addresses Unmet Needs for Certain Patients Treated With Prior ALK Therapy Read More »

Amgen (NASDAQ: AMGN) today announced that it is making Repatha® (evolocumab), an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, available at a reduced list price of $5,850 per year. Read More »

Taiho Oncology, Inc. announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF® Read More »

Pharmaceutical Care Management Association (PCMA) President and CEO JC Scott released the following statement on the Department of Health and Human Services’ proposal requiring drug companies to disclose the list price of prescription drugs in television ads Read More »

New safes for controlled substances will help combat opioid epidemic, reduce robbery incidents. All 228 CVS Pharmacy locations in Maryland area now using time-delay safe technology. Read More »

Researchers from the University of Central Florida recently received a $400,000 grant from the Juvenile Diabetes Research Foundation, which they will use to create a tube that resists infection and encapsulation and is inserted under the skin for the delivery of insulin via a pump. Read More »

A recent study published in European Endocrinology examined the effects of body lotions on capillary blood glucose measurement. Read More »

President Trump signed bipartisan legislation into law that will remove the barriers preventing pharmacists from helping patients find the least expensive way to purchase their prescription drugs. Read More »

The Pharmaceutical Care Management Association (PCMA) released the following statement on President Trump signing into law S. 2553/ S. 2554, the Know the Lowest Price Act of 2018 and the Patient Right to Know Drug Prices Act. Read More »

Health information technology (IT) should be the foundation of all business and clinical operations and not a secondary byproduct Read More »

Rite Aid Corporation (NYSE: RAD) released the following statement praising the U.S. Senate for passage of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6). Read More »