March 7th 2023
If approved, berdazimer could be the first prescription product treat molluscum, a common skin infection caused by poxvirus. The Prescription Drug User Fee Act goal date is Jan. 5, 2024.
February 11th 2023
November 17th 2022
September 30th 2022
September 20th 2022
FDA Accepts Dupixent Application for Treating Skin LesionsJune 1st 2022
If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.
Employers Face Barriers With Adopting BiosimilarsMarch 1st 2022
Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.
Actavis to buy Warner Chilcott for $8.5 billion in stock transactionMay 20th 2013
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.
FDA approves Sylatron for injection for adjuvant treatment of melanomaApril 12th 2011
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 warns of increased risk of death in patients administered tigecycline compared to other antibioticsNovember 12th 2010
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.