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The FDA grants a Fast Track designation to Spectrum Pharmaceuticals' (SPPI) poziotinib for treating non-small cell lung cancer in previously treated patients with HER2 exon 20 mutations.
Spectrum TV Stream is an American over-the-top internet television service owned by Charter Communications.The service – which is structured as a virtual multichannel video programming distributor – is only available to Charter Spectrum internet customers.
Spectrum Pharmaceuticals, Inc. is an American biopharmaceutical company located in Boston, MA.It develops and markets drugs for treatments in hematology and oncology.. After a deal valued at $248 million was announced in April 2023, [1] [2] Assertio Holdings announced that it had completed its acquisition of the Massachusetts-based company on July 31.
The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years. Cobenfy, manufactured by Bristol Myers Squibb ...
The FDA has granted a Complete Response Letter (CRL) to Spectrum Pharmaceuticals Inc's (NASDAQ: SPPI) marketing application seeking approval for poziotinib for previously treated locally advanced ...
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
A 2007 law directed the FDA to ensure that drug risk information appears “in a clear, conspicuous and neutral manner.” FDA has always required that ads give a balanced picture of both benefits and risks, a requirement that gave rise to those long, rapid-fire lists of side effects parodied on shows like “ Saturday Night Live.”
Pfizer's shot, Prevnar 20, was approved in 2021 for use in adults aged 18 years or older and protects against 20 serotypes. It is also approved for use in six-weeks old infants to 17-year olds.