February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

February 5, 2015

Food and Drug Commissioner Margaret Hamburg will resign from her post in March.

 

February 4, 2015

DSN examines chain pharmacy, including in-depth coverage of telehealth, generic drug prices, and the GPhA CEO to step down, as well as Uhl appointed director of OGD, in this multi-page report.

January 30, 2015

Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

January 21, 2015

Eisai on Tuesday announced the launch of a new savings card for Belviq (lorcaserin HCl) CIV, the most-prescribed branded FDA-approved prescription drug therapy for chronic weight management.

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

January 13, 2015

The Council for Responsible Nutrition and Informa Exhibitions (formerly Virgo) on Tuesday announced the continuation of their industry wide webinar series through 2015, with four webinars addressing key issues facing the industry.

January 8, 2015

Sandoz may be on track to receive the first biosimilar drug approval from the Food and Drug Administration for its Zarxio.

January 5, 2015

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a Q&A with Owen Mumford's Travis Shaw, in this multi-page report.

December 30, 2014

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

December 23, 2014

Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.

December 22, 2014

The Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

December 22, 2014

The Food and Drug Administration has granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.

December 22, 2014

The Food and Drug Administration has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

December 22, 2014

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

December 17, 2014

To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. 

December 16, 2014

Apira Science announced on Tuesday that the FDA has granted the company OTC clearance for its iGrow Hair Growth System to promote hair growth in women with Fitzpatrick skin phototypes I to IV, and with Ludwig Baldness Scale Classifications of I to II.

December 12, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at FDA reform and its potential impact on healthcare costs, in this multi-page report.

December 12, 2014

Sanofi Pasteur announced that the FDA approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine.

December 11, 2014

The Food and Drug Administration on Wednesday approved Gardasil 9 for the prevention of certain diseases caused by nine types of human papillomavirus.

December 5, 2014

The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

December 3, 2014

The Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.

 

December 1, 2014

The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015.