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News - September 2009

The Food and Drug Administration (FDA) announced the approval of the drug Folotyn (pralatrexate) September 25, 2009, as a treatment for peripheral T-cell lymphoma (PTCL), a typically aggressive form of non-Hodgkins lymphoma.

Manufactured by Allos Therapeutics Inc., Folotyn was approved by...

The Food and Drug Administration (FDA) approved a new drug used in the treatment of moderate to severe psoriasis on September 25, 2009. The approval of Stelara (ustekinumad) occurred following positive results from three studies evaluating the safety and efficacy of the drug on 2,266 patients....

Results newly released from a Danish study contribute to the evidence that the unborn babies of women taking antidepressants while pregnant may have an increased risk of developing a certain heart defect.

The study noted that while the overall risk for congenital heart problems (issues...

McNeil Consumer Healthcare, the makers of Tylenol, issued a voluntary recall of more than 20 different children and infant liquid products following the discovery of bacteria in an inactive ingredient used in the medicine. The products affected by the recall were manufactured more than a...

Coenzyme Q10 (CoQ10), a vitamin-like substance sold as a dietary supplement, has entered Phase III of a clinical trial testing its ability to slow the progression of Parkinson’s disease. Researchers at the Rush University Medical Center will participate in the large-scale study to determine if...

Three new cases of a rare brain inflammation have been linked to Tysabri, a prescription medication used to treat multiple sclerosis, confirmed the Food and Drug Administration (FDA).

The new cases of progressive multifocal...

On September 21, 2009, Incyte, a drug discovery and development company, announced positive news about a Phase II clinical trial involving a psoriasis medication.

Trial participants who used a topical treatment, janus kinase inhibitor (JAK) INCB18424, to treat their psoriasis presented...

The Food and Drug Administration (FDA) sent a warning letter to Bayer Pharmaceuticals last month regarding an inspection that took place in a Germany plant in March 2009. The letter stated the inspection revealed that the company deviated from current United States manufacturing practices for...

Certain lots of three different medications sold in Canada have been recalled by Apotex Inc., the largest Canadian-owned pharmaceutical company.

Selected lots of Apo-Amilzide 5-50 mg, Apo-Meloxicam 7.5 mg and 15 mg, and Apo-Ranitidine 75 mg and 150 mg are affected by the recall,...

Lexicon Pharmaceutical’s LX4211 drug, designed to treat type 2 diabetes, entered Phase II of a clinical trial in September 2009. After demonstrating favorable results in a Phase I clinical trial, the biopharmaceutical company decided to move forward with a second round of testing on the...

A study including 400 adult men and women diagnosed with functional dyspepsia, more commonly known as indigestion, is taking place at the three Mayo Clinic campuses across the United States in Florida, Minnesota and Arizona and Northwestern University, Saint Louis University School of...

GTx Inc. is in the process of conducting a Phase III clinical trial testing the use of toremifene, the company’s experimental drug, in the prevention of prostate cancer in men with a certain precancerous lesion of the prostate.  

Demerol, a medication used to alleviate pain, was thrust into the spotlight following the death of iconic pop singer Michael Jackson. The drug was allegedly injected into Jackson’s body right before he collapsed, implicating the medication as a possible...

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee determined the clinical data presented on Cervarix, GlaxoSmithKline’s candicate for a cervical cancer vaccine, adequately supported the safety and effectiveness of the vaccine.

The Food and Drug Administration (FDA) and Barr Laboratories, Inc. announced a nationwide recall in August for generic Adderall tablets distributed between June 11 and June 16, 2009. The recalled medication may be excessively potent due to the...

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