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Genmab has announced the FDA’s approval of Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia. Read More
The FDA has accepted the NDA for Mitsubishi’s edaravone drug, putting it on course to be the first approved treatment for amyotrophic lateral sclerosis (ALS) in more than 20 years. Read More
The California Supreme Court ruled that state courts have the jurisdiction to hear cases filed by out-of-state residents, clearing the path for an amended suit against Bristol-Myers Squibb that contends the company’s blood-thinner Plavix led to patient injuries. Read More
Vitalife received an FDA warning letter after an inspection revealed violations of the agency’s cGMP rules. The agency also challenged claims made on Vitalife’s website related to three of its products. Read More
The FDA has finalized a rule that will require pharmaceutical companies to electronically submit, list and register information on finished drug products and active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. Read More