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The FDA outlined its latest thinking on developing nicotine replacement therapy (NRT) drugs in a final guidance released Monday, including detailed recommendations for clinical trials to support product applications. Read More
Astellas Pharma has acquired Iveric Bio in a $5.9 billion deal that brings the Japanese biotech Iveric’s avacincaptad pegol (ACP), an investigational intraocular injection for geographic atrophy secondary to age-related macular degeneration. Read More
Ascendis Pharma of Denmark got slapped with a Complete Response Letter (CRL) in which the FDA voiced concerns about the variability in the delivered dose of the company’s investigational treatment for adults with hypoparathyroidism. Read More
The FDA’s ability to function is threatened by the loss of public respect for the agency’s science-based decision making, which is “arguably at an all-time low,” said Steven Grossman, executive director of the Alliance for a Stronger FDA. Read More
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with one abstention to recommend that the FDA restrict approval for the combination of AstraZeneca’s blockbuster cancer drug Lynparza (olaparib) and Zytiga (abiraterone) to just metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors have a breast cancer gene (BRCA) mutation. Read More
Takeda has another shot on goal for a self-administered subcutaneous form of its blockbuster Entyvio (vedolizumab) as maintenance treatment for patients with ulcerative colitis who have completed induction therapy with the antibody’s intravenous form. Read More
Over the past week, the FDA issued an authorization of a medical device, a request for comments for a public workshop and proposed data and information collections. Read More
The European Medicines Agency’s (EMA) human medicines committee has signed off on GSK’s Arexvy (recombinant, adjuvanted), the first respiratory syncytial virus (RSV) vaccine for adults age 60 years and older as well as six other new drugs at its latest monthly meeting. Read More