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FDA expands Pfizer and Astellas' Xtandi into castration-resistant prostate cancer pharmafile
July 17, 2018
Astellas and Pfizer have revealed that their androgen receptor inhibitor Xtandi (enzalutamide) has received approval from the FDA to expand its label indications to include the treatment of metastatic castration-resistant prostate cancer (CRPC).
FDA approves first smallpox therapy to defend against bioterrorism pharmafile
July 17, 2018
The FDA has announced that it has awarded marketing authorisation to SIGA Technologies’ TPOXX (tecovirimat) in the first approval of a drug specifically designed to treatment smallpox. But as the disease was wiped out in 1980, the motivation behind the de
FDA approves first smallpox therapy pharmatimes
July 17, 2018
US regulators have approved the first treatment designed to mitigate the impact of a potential outbreak of smallpox caused by bioterrorism.
Purdue defends against opioid lawsuits by pointing to FDA regulations it helped create fiercepharma
July 17, 2018
Purdue is defending itself against lawsuits around the country alleging it downplayed opioid risks and overstated their benefits.
US expands use of Shire’s Vonvendi pharmatimes
July 16, 2018
US regulators have expended the scope of Shire’s Vonvendi to include perioperative management of bleeding in adults with von Willebrand disease (VWD).
Rigel bags first FDA approval pharmatimes
July 16, 2018
Rigel Pharmaceuticals has bagged its first FDA approval, with a green light to market Tavalisse for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have failed to respond to previous treatment.
FDA advisors back approval of GW’s Epidiolex pharmatimes
July 16, 2018
As expected, an FDA advisory panel has backed approval of GW Pharmaceuticals/Greenwich Bioscience’s Epidiolex for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
FDA approval for Novartis' melanoma combo pharmatimes
July 12, 2018
The FDA has approved Novartis' Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma, as detected by an FDA-approved test, and involvement of lymph nodes, following comp
FDA approves Merz’s Xeomin for sialorrhea pharmaceutical-technology
July 12, 2018
The US Food and Drug Administration (FDA) has approved Merz North America’s supplemental biologics license application for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, otherwise known as excessive drooling.
Elite Pharmaceuticals Receives FDA Approval for Generic Percocet americanpharmaceuticalreview
July 11, 2018
Elite Pharmaceuticals has received approval of the company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic Percocet (Oxycodone Hydrochloride and Acetaminophen, USP CII) 5 mg/325 mg, 7.5 mg/325 mg and

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