| Today’s Big NewsNov 17, 2023 |
| By Annalee Armstrong Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner. |
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By Andrea Park The virtual meeting scheduled February 2 will bring together the FDA's anesthesiology and respiratory therapy devices advisory panel. |
By Nick Paul Taylor Karuna Therapeutics has ticked another task off the to-do list for its blockbuster-in-waiting KarXT, posting phase 1b data that counter concerns about the effect of the schizophrenia therapy on blood pressure. |
By Angus Liu After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. But an unexpected restriction has cast a dark cloud over the first-in-class approval. |
By Conor Hale The FDA issued a Class I recall for the 5,700 defective scopes that were stolen after being marked for scrap, then put up for sale on social media. |
By Helen Floersh Preclinical tests of Rome Therapeutics' first-of-its-kind drug show that it’s effective in reducing a type of inflammation believed to promote autoimmune diseases like lupus. |
By Kevin Dunleavy The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. |
By Conor Hale A malfunction that could cause Asensus Surgical’s robotic system to move unexpectedly has received the most serious classification from the FDA. |
By Andrea Park More than a year after announcing plans to spin out its healthcare business as a standalone company, 3M has finally revealed the name of that soon-to-be-formed entity. |
By Fraiser Kansteiner AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing. AZ plans to find a buyer who can also serve as a contract manufacturer for the drugs produced there. |
By Max Bayer,Gabrielle Masson Janet Woodcock is set to retire from the FDA after nearly 40 years at the agency. Madrigal names ex-Sanofi leaders as new CCO. Mural unveils with a pair of seasoned clinical development leaders. |
Fierce podcasts Don’t miss an episode |
| This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge. |
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