Food and Drug Administration approvals has been tempered by a long list of phase 3 trial disappointments.Oncology agents led the way, starting with two drugs being studied for the treatment of non-small cell lung cancer. The addition of Eli Lilly's pemetrexed (Alimta) to a regimen of ...
Ivo Abraham, Professor Of Pharmacy Practice And Science, University of Arizona Prasad Adusumilli, Deputy Chief, Thoracic Surgery, Vice Chair, Department Of Surgery, Memorial Sloan-Kettering Cancer Center Teresa Ai, Director of Early Product Marketing, Stealth Anupam Aich, Product Definition Lead, Cl...
A biosimilar is not considered a “generic” in the same way that a traditional, small molecule drug (for example: ibuprofen or acetaminophen) is determined to be a generic. Biosimilars are "similar" because they are biologics that do not have to be exact copies of the active ingredient, as...
The SPIRIT-Outcomes 2022 Extension Mass Violence and the Complex Spectrum of Mental Illness and Mental Functioning Neuropsychiatry Sequelae of COVID-19 A New Framework for Dementia Nomenclature Organization and Performance of US Health Systems Pharmacy Benefit Managers: History, Business Practices, Economics...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicul
Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug r
Assessing the role of delivery systems to improve biologics therapy, alternative routes of administration could greatly benefit many biologics, reported Nataša Škalko-Basnet (professor and head of the Drug Transport and Delivery Research Group, Department of Pharmacy, University of Tromsø, Norway...
Food and Drug Administration, HHS. Final rule. The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the ... ...
Therefore, they paved the way to improve the patients’ quality of life by significantly reducing the treatment time for patients, physicians, nurses and pharmacy staff. This sub-cutaneous formulation brings opportunities for more flexible home management of patients with cancer. However, not all ...