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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
Amgen published positive results from a Phase III trial comparing Prolia (denosumab) with risedronate in patients receiving oral glucocorticoid therapy. The study met all primary and secondary endpoints at 12 months. 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
Tonix Pharmaceuticals reported that the FDA has accepted the company’s proposed Phase III studies and planned NDA data package, following an end-of-Phase II meeting on its sublingual tablet for the treatment of post-traumatic stress disorder, TNX-102 SL. 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
Drug sponsors that have falsified data will face three years of probation before being allowed to refile marketing applications, the Chinese FDA says. Read More
A Phase III trial of the flutiform inhaler did not meet its primary endpoint of demonstrating statistically significant superiority in the reduction of annualized rates of moderate and severe exacerbations of chronic obstructive pulmonary disease, when compared to mono-component long-acting β2-agonist treatment alone. Read More