Oncology Times

Skip Navigation LinksHome > Collections > FDA News

FDA News

Creator:   Editor
Created:   7/14/2014
Contains:  198 items
Actions, updates, and special reports from the U.S. Food and Drug Administration about oncology-related drugs.

Show
Previous of 2 Next

Venetoclax Approved for Patients With Chronic Lymphocytic Leukemia

Free Access
PDF
+ Favorites
Request Permissions

New Treatment for People With Metastatic Non-Small Cell Lung Cancer

Free Access
PDF
+ Favorites
Request Permissions

Treatment Available for Severe Hepatic Veno-Occlusive Disease

Free Access
PDF
+ Favorites
Request Permissions

Treatment Available for Severe Hepatic Veno-Occlusive Disease

Free Access
PDF
+ Favorites
Request Permissions

Enhanced Warnings for Immediate-Release Opioid Pain Medications

Free Access
PDF
+ Favorites
Request Permissions

Proposal to Eliminate the Use of Powdered Gloves in Health Care Announced

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Afinitor (Everolimus) for GI & Lung NETs

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Imbruvica (Ibrutinib for CLL)

Free Access
PDF
+ Favorites
Request Permissions

FDA Grants Priority Review to Atezolizumab for mUC

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Therapy Designation to PKC412 (Midostaurin) for AML

Free Access
PDF
+ Favorites
Request Permissions

FDA Expands Approved Use of Ibrance (Palbociclib) for HR+, HER2- Metastatic Breast Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Halaven (Eribulin Mesylate) Injection for Liposarcoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Grants Priority Review to Lenvatinib Combo Therapy for RCC

Free Access
PDF
+ Favorites
Request Permissions

FDA Updates in Ovarian Cancer, NHL, and MRTs

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Kyprolis Combo Therapy for Relapsed/Refractory Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

Venetoclax Granted Another FDA Breakthrough Therapy Designation—this Time for AML

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Opdivo-Yervoy Combo, Opdivo Single-Agent Therapy for New Indications in Metastatic Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Therapy Status to Venetoclax Combo Therapy for CLL

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Tafinlar+Mekinist Combo for Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Bendeka (Bendamustine Hydrochloride) Injection for CLL and NHL

Free Access
PDF
+ Favorites
Request Permissions

FDA's Orphan Drug Designation to ARQ 087 for Cholangiocarcinoma

Free Access
PDF
+ Favorites
Request Permissions

FDA's Fast Track Status to Brilacidin-OM for Oral Mucositis

Free Access
PDF
+ Favorites
Request Permissions

FDA Breakthrough Therapy Status to Third-Generation TKI, BI 1482694, for NSCLC

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Keytruda for Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Opdivo for Advanced Renal Cell Carcinoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Opdivo as Single Agent for Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Clears Device to Reduce Hair Loss during Chemotherapy

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Alecensa (Alectinib) for ALK-Pos NSCLC

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves First Emergency Treatment for Chemotherapy Overdose

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Portrazza for Advanced Squamous NSCLC

Free Access
PDF
+ Favorites
Request Permissions

FDA Priority Review Status to Drugs for Metastatic Breast Cancer and NSCLC

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Empliciti & Ninlaro for Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

FDA Breakthrough Therapy Designation to Avelumab for Merkel Cell Carcinoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Darzalex for Previously Treated Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approval for New Targeted NSCLC Drug

Free Access
PDF
+ Favorites
Request Permissions

FDA Clears Another High-Intensity Focused Ultrasound Treatment for Prostate Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Cotellic Combo Therapy for Advanced Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Therapy Designation to Keytruda for Advanced Colorectal Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves First Oncolytic Virus Therapy: Imlygic for Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA's Orphan Drug Designation to STM 434 for Ovarian Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Therapy & Orphan Drug Designations to Drug for Tenosynovial Giant Cell Tumor

Free Access
PDF
+ Favorites
Request Permissions

Ipilimumab Approved for Adjuvant Use in Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Priority Review to CLL and Myeloma Drugs

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Opdivo for Non-Squamous NSCLC

Free Access
PDF
+ Favorites
Request Permissions

FDA Clears Focused Ultrasound System for Prostate Cancer Treatment

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Yondelis for Soft Tissue Sarcoma Subtypes

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Onivyde Combo Regimen for Advanced Pancreatic Cancer

Free Access
PDF
+ Favorites
Request Permissions

3 Questions on... The New Way(s) to Get Oncology Drugs Approved: With Suparna B. Wedam, MD, Medical Officer at the FDA

Free Access
PDF
+ Favorites
Request Permissions

Opdivo-Yervoy Combination Approved for Melanoma—First Combination-Immunotherapy Regimen for Cancer

Free Access
PDF
+ Favorites
Request Permissions

Approval for Optune Device for Glioblastoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Breakthrough Therapy Designation to Abemaciclib for Breast Cancer

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Status to Sarcoma Drug

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves New Oral Drug for Advanced Colorectal Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Priority Review Status for Defibrotide and Halaven

Free Access
PDF
+ Favorites
Request Permissions

Priority Review to Two Drugs for Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

Daratumumab Receives FDA Priority Review for Double-Refractory Myeloma

Free Access
PDF
+ Favorites
Request Permissions

Priority Review & Breakthrough Status to Opdivo for Non-Squamous NSCLC & RCC

Free Access
PDF
+ Favorites
Request Permissions

FDA's Orphan Drug Designation to Toca 511 & Toca FC for Glioblastoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Actions for RCC and ITP Drugs

Free Access
PDF
+ Favorites
Request Permissions

FDA Grants Priority Review to MCNA for Bladder Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approval for Two Antiemetics

Free Access
PDF
+ Favorites
Request Permissions

Priority Review to Keytruda for First-Line Treatment of Advanced Melanoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Clearance for First Low-Dose CT Lung Cancer Screening System

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves New Formulation of Onsolis for Breakthrough Pain

Free Access
PDF
+ Favorites
Request Permissions

FDA's Orphan Drug Status to Inecalcitol for AML

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Adcetris for Another HL Indication

Free Access
PDF
+ Favorites
Request Permissions

New Cancer-Related FDA Actions

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Status to Melphalan for Cholangiocarcinoma

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Designation to Anisina for Neuroblastoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Iressa for NSCLC, along with Companion Diagnostic

Free Access
PDF
+ Favorites
Request Permissions

Priority Review for MM-398 for Metastatic Pancreatic Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Promacta for Children with Chronic ITP

Free Access
PDF
+ Favorites
Request Permissions

FDA's Priority Review to Glioblastoma Therapy for Second Indication

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Designation to Venetoclax for CLL

Free Access
PDF
+ Favorites
Request Permissions

FDA Actions for Keytruda for NSCLC and GMI-1271 for AML

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Metastatic Colorectal Cancer KRAS Mutation Test

Free Access
PDF
+ Favorites
Request Permissions

FDA Gives Fast Track Designations to Drugs for AML, Pancreatic Cancer, NSCLC, and Prevention of Oral Mucositis

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Designation to Cantrixil for Ovarian Cancer and Selumetinib for Uveal Melanoma

Free Access
PDF
+ Favorites
Request Permissions

Priority Review to Post-Transplant Consolidation Treatment for Hodgkin Lymphoma

Free Access
PDF
+ Favorites
Request Permissions

Xalkori Gets FDA Breakthrough Therapy Designation for NSCLC Indication

Free Access
PDF
+ Favorites
Request Permissions

Two FDA Advisory Committees Recommend Approval of Talimogene for Metastatic Melanoma

Free Access
PDF
+ Favorites
Request Permissions

Cometriq (Cabozantinib) Granted Fast Track Designation for Advanced RCC

Free Access
PDF
+ Favorites
Request Permissions

Rucaparib Gets FDA Breakthrough Therapy Status for Ovarian Cancer

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Status Given to IMO-8400 for Diffuse Large B-Cell Lymphoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approval for Label Update for Zytiga; Orphan Drug Status for Reolysin and CRS-07

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves New Oral Formulation of Deferasirox (Jadenu) for Chronic Iron Overload

Free Access
PDF
+ Favorites
Request Permissions

FDA Grants Priority Review to Kyprolis for Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

FDA's Fast Track Status to Nonmuscle-invasive Bladder Cancer Drug

Free Access
PDF
+ Favorites
Request Permissions

Glioblastoma Drug Gets FDA Breakthrough Therapy Designation

Free Access
PDF
+ Favorites
Request Permissions

FDA Approval for Unituxin for Pediatric High-risk Neuroblastoma

Free Access
PDF
+ Favorites
Request Permissions

FDA Expands Approved Use of Opdivo (Nivolumab) for Lung Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves First Biosimilar for United States: Zarxio (Filgrastim-sndz)

Free Access
PDF
+ Favorites
Request Permissions

Orphan Drug Designation to LEP-ETU for Ovarian Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Actions for Drugs for EBV Lymphoproliferative Disease and Fallopian Tube Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Expands Revlimid Indication for All Patients with Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

FDA Approves Farydak (Panobinostat) for Multiple Myeloma

Free Access
PDF
+ Favorites
Request Permissions

Approval for Palbociclib for Metastatic Breast Cancer

Free Access
PDF
+ Favorites
Request Permissions

FDA Priority Review to Soft Tissue Sarcoma Drug

Free Access
PDF
+ Favorites
Request Permissions

FDA Approval for Lenvatinib for Thyroid Cancer Indication

Free Access
PDF
+ Favorites
Request Permissions

FDA's Breakthrough Designation to Anti-PDL1 Immunotherapy for NSCLC

Free Access
PDF
+ Favorites
Request Permissions
Show
Previous of 2 Next
Collection Alerts

Stay up-to-date! Be notified every time a new item is added. Receive an Email or subscribe to an RSS feed.