May 6, 2014

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck's allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report.

May 6, 2014

Pfizer's Nexium 24HR will launch May 27, Pfizer reported in a conference call Monday.

May 5, 2014

The Generic Pharmaceutical Association on Monday hired Felecia Tan for the role of AVP sciences and regulatory affairs.

May 5, 2014

Teva Pharmaceutical Industries on Monday announced that the Food and Drug Administration approved Synribo (omacetaxine mepesuccinate) for injection, to include home administration.

May 1, 2014

GlaxoSmithKline on Wednesday announced that the Food and Drug Administration approved Incruse Ellipta (umeclidinium), which is used for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and/or emphysema.

May 1, 2014

Purdue Pharma on Wednesday announced that it filed a new drug application with the Food and Drug Administration to market a hydrocodone bitartrate tablet, which is formulated to incorporate abuse-deterrent technology.

April 30, 2014

The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

April 29, 2014

Jubilant Life Sciences, an integrated pharmaceuticals and life sciences company, last week announced that it received approval from the Food and Drug Administration for spironolactone tablets, 25 mg, 50 mg and 100 mg, which is the generic version of Aldactone.

April 28, 2014

Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer's Celebrex.

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.