Food and Drug Administration (FDA)
NEWS
This morning, San Diego-based Illumina, Inc. announced that Gottlieb joined its board of directors effective Feb. 4.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
For the millions of people suffering from an allergy to peanuts, there is a new, first-of-its-kind treatment available. On Friday, the U.S. Food and Drug Administration approved Aimmune Therapeutics’ oral immunotherapy AR101.
The study notes that about half of recent drug approvals were built on a single pivotal clinical trial. Typically, two pivotal, Phase III trials were the norm.
The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Coherus BioSciences, Inc. announced the Company has entered into a licensing agreement with Innovent Biologics, Co., Ltd.,, a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® in the United States and Canada.
The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
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