Merck announced positive results from the late-stage KEYNOTE-522 study for Keytruda as a neoadjuvant treatment for triple negative breast cancer, which should support the company’s previous attempt for U.S. approval that was stymied by a regulatory advisory committee in February and rejected by the Food and Drug Administration in March.
The U.S. Food and Drug Administration released a briefing document on May 4 citing concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. ChemoCentryx is seeking approval from the FDA for the drug as a therapeutic agent for anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV).
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to Biogen’s experimental drug aducanumab for Alzheimer’s disease in a JAMA article.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
Johnson & Johnson expects to be able to ship nearly 4 million doses of the company’s Covid-19 vaccine upon authorization in the U.S., an executive said at a hearing in the U.S. House of Representatives on Feb. 23.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.
A panel of outside advisers to the U.S. Food and Drug Administration overwhelmingly endorsed emergency use of Moderna Inc.’s coronavirus vaccine, virtually assuring a second option for protecting against Covid-19 for a pandemic-ravaged nation.
The U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 17-4 to recommend Pfizer and BioNTech’s Covid-19 vaccine for Emergency Use Authorization (EUA) for individuals ages 16 years and older.