FibroGen Provides Regulatory Update on Roxadustat
SAN FRANCISCO, Dec. 18, 2020 (GLOBE NEWSWIRE) FibroGen, Inc. (Nasdaq: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) by three months. The updated Prescription Drug User Fee Act (PDUFA) action date is March 20, 2021.
The FDA is close to finalizing its review of the NDA and FibroGen is submitting additional analyses of existing roxadustat clinical data, which require an extension of the original PDUFA date.
“FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat,” said Enrique Conterno, Chief Executive Officer, FibroGen. “There is significant unmet medical need for the treatment of anemia of CKD, and we are committed to bringing roxadustat to patients in the
Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy homenewshere.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from homenewshere.com Daily Mail and Mail on Sunday newspapers.
Published: Dec 16, 2020 By Joseph Constance
A healthy immune system defends the body against disease and other conditions. However, if the immune system malfunctions, it can attack healthy cells, tissues and organs. Autoimmune disease impacts different parts of the body, weakening functionality. It may be life-threatening.
Researchers are aware of more than
80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. The more common autoimmune diseases include type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus and inflammatory bowel disease.
Autoimmune diseases affect more than
24 million people in the U.S. On top of this, another 8 million carry auto-antibodies, blood molecules that indicate a person’s chance of developing an autoimmune disease. The cause of many of the diseases is unknown.
Published: Dec 15, 2020
NEWTON, Mass., Dec. 15, 2020 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Michael Mano as Senior Vice President, General Counsel. Mr. Mano brings over 15 years of legal experience and previously served as Counsel, Business Development at Biogen Inc. Michael s depth of legal experience, particularly in the public life science sector supporting partnerships, intellectual property licensing, corporate governance, and financing efforts, will be valuable to Karyopharm as we continue to grow our commercial business and work to expand the reach of XPOVIO and our other pipeline assets worldwide, said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm.
Karyopharm Announces National Comprehensive Cancer Network® Adds Three XPOVIO® (selinexor) Treatment Regimens to Its Clinical Practice Guidelines in Oncology for Multiple Myeloma
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NEWTON, Mass., Dec. 11, 2020 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the National Comprehensive Cancer Network® (NCCN) added three different XPOVIO® (selinexor) combination regimens to its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for previously treated multiple myeloma. The XPOVIO regimens added to the NCCN guidelines, include: (i) selinexor / bortezomib / dexamethasone (once-weekly) (SVd); (ii) selinexor / daratumumab / dexamethasone (SDd); and (iii) selinexor / pomalidomide / dexamethasone (SPd), which is an all-oral treatment regimen. Importantly, the once weekly SVd regimen received a Category 1 recommendat