June 17, 2014

Novartis on Tuesday announced that it had submitted a biologic license application to the Food and Drug Administration for marketing approval for the use of Bexsero.

June 12, 2014

Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.

June 11, 2014

Strativa Pharmaceutical, a division of Par Pharmaceutical Cos., announced that the Food and Drug Administration approved Nascobal, a prescription B-12 supplement administered once a week as one spray.

June 10, 2014

The Food and Drug Administration last week published an interim final rule to further safeguard the health of infants fed infant formula in the United States.

June 9, 2014

BioDelivery Sciences International on Monday announced that the Food and Drug Administration approved its new drug application for Bunavail (buprenorphine and naloxone) buccal film (CIII).

June 9, 2014

A recently approved drug might make infusions for hemophiliacs fewer and further between. The Food and Drug Administration approved Biogen Idec's Eloctate, which clinical trials have shown works to treat bleeding episodes and to increase the time between prophylactic blood infusions for those with hemophilia A.

June 3, 2014

Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

June 2, 2014

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

May 30, 2014

Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.

May 29, 2014

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.

May 23, 2014

The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections.

May 23, 2014

Teva Pharmaceutical on Friday announced that the Food and Drug Administration approved the use of QVAR (beclomethasone dipropionate HFA) with a dose counter for the treatment of asthma in patients 5 years of age and older.

May 16, 2014

Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.

May 15, 2014

The stampede of big-selling branded medicines that hurtled off the patent cliff in 2011 and 2012 has slowed to a relative trickle.

May 14, 2014

The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.

May 6, 2014

Walgreens immunoglobulin home infusion patients reported health outcomes consistent with reported outcomes gathered by the patients’ physicians in the clinical setting, according to new Walgreens PartnerPoint Clinical Management platform data presented Friday at the American Academy of Neurology 2014 Annual Meeting in Philadelphia.

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.

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 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 28, 2014

U.S. pharmaceutical firm Pfizer this morning confirmed discussions with AstraZeneca regarding a possible merger. If the transaction goes through, it's expected that the two companies will combine under a new U.K-incorporated holding company.

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 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 17, 2014

Teva Pharmaceutical announced that its U.S. subsidiary has entered into a settlement with Pfizer related to Teva's generic version of Celebrex (celecoxib) 50-, 100-, 200- and 400-mg capsules in the United States.

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.