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Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...

The FDA has approved Bristol Myers Squibb’s (BMS ... RCC accounts for approximately nine out of 10 kidney cancer diagnoses, making it the most common form. In turn, eight out of 10 RCC diagnoses are ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

After a priority review, the FDA did not approve an injectable form of Rybrevant, a Johnson & Johnson medication for non-small cell lung cancer. The rejection is not due to the therapy's ...