Category: New Drugs
-
FDA Approves Armlupeg – New Pegfilgrastim Biosimilar
The U.S. Food and Drug Administration has approved Armlupeg™ (pegfilgrastim‑unne) as a biosimilar to Neulasta® (pegfilgrastim) for decreasing the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy, and for increasing survival after acute exposure to myelosuppressive radiation. This approval adds another pegfilgrastim biosimilar to the U.S. market and
-
FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review
The U.S. Food and Drug Administration (FDA) has approved a reformulated ranitidine tablet after a comprehensive safety review addressing prior concerns about N‑nitrosodimethylamine (NDMA) impurity formation; the approval includes updated storage and handling requirements to mitigate impurity risk and preserve product stability. Background and regulatory context Ranitidine, an H2‑receptor antagonist widely used for gastroesophageal reflux
-
FDA Approves Ziftomenib for Acute Myeloid Leukemia
The treatment landscape for acute myeloid leukemia (AML) has recently seen a significant development with the U.S. Food and Drug Administration (FDA) granting full approval to ziftomenib (Komzifti™) for adult patients diagnosed with relapsed or refractory (R/R) AML who harbor a susceptible NPM1 (Nucleophosmin 1) mutation and have no satisfactory alternative treatment options. This landmark
-
Breakthrough Cancer Drug With No Detectable Side Effects
A significant nanomedicine breakthrough from Northwestern University, led by Prof. Chad A. Mirkin and documented in the peer-reviewed journal ACS Nano, details the transformation of the chemotherapy agent 5-fluorouracil (5-Fu) into a spherical nucleic acid (SNA) structure. According to both the article and surrounding scientific coverage, this innovation reports unprecedented increases in cancer cell targeting
-
ADRIANA Pain Medication – A Promising Future Alternative to Opioids
The opioid crisis has devastated communities worldwide, particularly in the United States, where opioid overdoses claimed more than 80,000 lives in 2023 alone.¹ While opioids like morphine and oxycodone remain powerful tools for managing severe pain, their risks —including addiction, overdose, and long-term dependence — have created an urgent need for safer alternatives. Enter ADRIANA