Will Sppi get FDA approval?
–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of Beleodaq™ for the …
What does Spectrum Pharma do?
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology. Spectrum has a strong track record for in-licensing and acquiring differentiated drugs, and for clinical development.
What is Rolontis for?
The FDA turned down Rolontis’ application to treat neutropenia in cancer patients on myelosuppressive therapies.
Is Spectrum Pharmaceuticals a good buy?
Spectrum Pharmaceuticals has received a consensus rating of Buy. The company’s average rating score is 3.00, and is based on 2 buy ratings, no hold ratings, and no sell ratings.
Why is Spectrum Pharmaceuticals stock dropping?
Why Spectrum Pharmaceuticals Stock Is Crashing Today The big decline came after the company announced that the U.S. Food and Drug Administration turned down approval of Rolontis in treating neutropenia in patients receiving cancer drugs that decrease bone marrow activity.
How does FDA pay?
FDA allows on-line payment by credit card and ACH (Automated Clearing House) electronic checks. Follow the on screen instructions to make payment. Confirmation of payment made by credit card or electronic check can be received in as little as 24 hours.
When did the FDA issue a warning letter to spectrum?
FDA cited similar CGMP deviations at another facility in your company’s network. We issued a warning letter to Spectrum Laboratory Products, Inc., FEI 2020632, in Gardena, California on June 4, 2019, citing similar CGMP deviations for lack of supply chain traceability.
Who is spectrum laboratory products, inc.fei 2246824?
According to the sales record obtained at the time of inspection, Spectrum Laboratory Products Inc., FEI 2246824, repackages and relabels drugs for commercial distribution in the United States, of which some have not been listed with FDA as required by the law.
Where is spectrum laboratory products in New Brunswick NJ?
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Spectrum Laboratory Products, Inc., FEI 2246824, at 755, 769, and 777 Jersey Avenue, New Brunswick, New Jersey, from February 19, 2019 to March 12, 2019.
What are the proposed changes to the FDA?
It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.