Regulatory
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 19, 2021.
Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has become the first HER2-directed medication approved to treat gastric cancer in the U.S. in 10 years.
The U.S. Food and Drug Administration approved Janssen Pharmaceuticals’ Darzalex Faspro for adults with newly diagnosed light chain amyloidosis.
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up. Here’s a look.
The U.S. FDA approved Pfizer’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.
Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for Priority Review.
The U.S. Food and Drug Administration is experiencing abrupt and noticeable personnel changes as it continues to clash with the Health and Human Services, the department that oversees the agency and its operations.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 12, 2021.
PRESS RELEASES