April 24, 2014

The Food and Drug Administration on Thursday approved a human papillomavirus DNA test for women 25 years of age and older that can be used to help health care professionals assess the need for a woman to undergo additional testing for cervical cancer.

April 24, 2014

The Food and Drug Administration on Wednesday approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease, a rare disorder similar to lymphoma (cancer of the lymph nodes).

April 24, 2014

The Food and Drug Administration on Thursday proposed a new rule that would extend the agency's tobacco authority to cover additional tobacco products. The proposal is part of the FDA's implementation of the Family Smoking Prevention and Tobacco control Act, which was signed by President Barack Obama in 2009.

April 23, 2014

Bayer HealthCare on Tuesday announced that the Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for Bayer's investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis.

April 23, 2014

Specialty pharmacy operator Diplomat has access to dispense Arzerra, a cancer treatment with a recently expanded indication, the company noted Tuesday.

April 22, 2014

Eli Lilly on Monday announced that the Food and Drug Administration has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

April 21, 2014

Boehringer Ingelheim Pharmaceuticals has announced that the Food and Drug Administration and European Commission have granted Orphan Drug Designation to volasertib for acute myeloid leukemia.

April 21, 2014

GlaxoSmithKline and Genmab A/S announced last week that the Food and Drug Administration has approved a supplemental biologic license application for the use of Arzerra (ofatumumab) in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia for whom fludarabine-based therapy is considered inappropriate.

April 21, 2014

Mylan on Friday announced that Supreme Court Chief Justice John Roberts has denied Teva's application for an injunction seeking to prevent Mylan's launch of a generic version of Copaxone (glatiramer acetate injection) pending the Supreme Court's decision on Teva's appeal.

April 18, 2014

Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U).

April 15, 2014

The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets.

April 15, 2014

Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use.

April 15, 2014

The Food and Drug Administration on Tuesday announced that it approved Tanzeum (albiglutide) subcutaneous injection, which is used to improve glycemic control in adults with Type 2 diabetes.

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

April 11, 2014

Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg.

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

April 8, 2014

Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.”

April 8, 2014

The Natural Products Association on Tuesday named Daniel Fabricant the association's new CEO.

April 8, 2014

Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.

April 8, 2014

Teva Pharmaceutical Industries announced that it has received approval from the Food and Drug Administration for its generic form of Lovaza (omega-3-acid ethyl esters capsules, USP) in the United States.

April 7, 2014

Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate), which is used to treat deep venous thrombosis and pulmonary embolism.

April 7, 2014

The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

April 4, 2014

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April 4, 2014

The National Association of Boards of Pharmacy recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.