Clinical

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FDA has approved dabrafenib (Tafinlar, GlaxoSmithKline) and trametinib (Mekinist, GlaxoSmithKline) for patients with advanced (metastatic) or unresectable melanoma.

FDA approves dabrafenib and trametinib for advanced skin cancer

Actavis Inc. announced May 20 its plans to acquire Warner Chilcott in a stock transaction deal, which is worth approximately $8.5 billion. The merger is expected to create a global specialty pharmaceutical company serving the women’s health, gastroenterology, urology, and dermatology therapeutic sectors, according to a joint company release.

Actavis to buy Warner Chilcott for $8.5 billion in stock transaction

FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.

FDA approves first topical acne treatment in children aged 9 and up

The FDA has released a safety communication alerting healthcare providers to a new risk evaluation and mitigation strategy for ipilimumab.

FDA cautions prescribers of risk for severe immune-mediated adverse reactions with ipilimumab use

FDA has approved peginterferon alfa-2b (Sylatron, Merck) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

FDA approves Sylatron for injection for adjuvant treatment of melanoma

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA approves new treatment for a type of late-stage skin cancer

FDA approves new treatment for late-stage skin cancer

In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections.

FDA warns of increased risk of death in patients administered tigecycline compared to other antibiotics

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)