Ceritinib has been granted Priority Review as a first-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
First-in-class drugs are fast-tracked while follow-on drugs can take up to 15 years to be approved by the FDA.
Rucaparib has been approved for the treatment of patients with advanced ovarian cancer who harbor a deleterious BRCA mutation.
The US FDA has granted approval for additional indications for daratumumab for the treatment of patients with multiple myeloma who have received prior therapies.
Atezolizumab (Tecentriq) is approved by the FDA for the treatment of metastatic NSCLC in specific cases or tumors with EGFR or ALK gene mutations.
The US Food and Drug Administration has approved ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of relapsed chronic lymphocytic leukemia (CLL).
US FDA standards demand that surrogate end points used in clinical trials be "reasonably likely to predict" survival for accelerated approval, or be established proxies for survival for traditional approval; however, surrogate end points used frequently lack formal study.
The US FDA has granted Priority Review to ofatumumab used in combination with fludarabine and cyclophosphamide for the treatment of chronic lymphocytic leukemia.
Added sugars and relevant portion sizes are among the highlights of this food label revision.
US FDA granted accelerated approval to atezolizumab (TECENTRIQ), indicated for the treatment of locally advanced or metastatic UC in patients whose disease progressed during or following platinum-based chemotherapy, or in the neoadjuvant or adjuvant setting.
This fact sheet explains investigational drugs and the process by which cancer patients may obtain them.
Next week, FDA committee of outside experts will meet to review risk-management plans
Recent survey data indicates that the majority of respondents held incorrect beliefs about both U.S. Food and Drug Administration (FDA) approval standards.
In the latest step to combat the epidemic of opioid abuse, U.S. officials urge generic drug makers to make changes to opioids.
Mainly supportive of guidelines, but concerns include a lack of evidence underlying some new recommendations.
New research has helped influence the FDA's decision to approve the first immunotherapy for pediatric patients.
This newly approved drug operates by targeting the PD-1/PD-L1 cellular pathway.
This new oral medication blocks certain enzymes, hindering cancer-cell growth.
Approved for use with PD-L1 IHC 22C3 pharmDx test
The combination pill Lonsurf has been approved for patients with metastatic CRC not responding to other therapies.
New companion diagnostic kit can identify candidates
A novel mechanism has been discovered that can lead melanoma cells to develop resistance to drugs that target the protein BRAF.
International effort takes aim at more than 1,050 websites that sell fraudulent medical devices or medications.
The ACP has released a position paper suggesting the FDA adopt e-cigarette ad and flavoring bans; backers of devices say bans may drive some smokers back to cigarettes.
First approval for a therapy aimed specifically to treat the rare pediatric cancer
Zarxio (filgrastim-sndz) is the first biosimilar product approved by the U.S. Food and Drug Administration (FDA) in the United States.
FDA approves drug for NSCLC patients who have been treated with platinum-based chemotherapy
Drug is now sanctioned for people who have received at least two prior standard therapies.
Ibrance (palbociclib) has been approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women with ER, HER2-negative metastatic breast cancer.
Medication helps harness immune system to attack melanoma.
- Cabozantinib Activates Innate Immune Response, Eliminating Prostate Cancer
- Shorter Treatment of Breast Cancer with Trastuzumab May Lead to Improved Results
- Risk of Second Cancers Increased in Hodgkin Lymphoma Survivors
- Directly Informing Patients of Breast Cancer Risk, Options Improves Follow-Up Screening
- Kidney Cancer Metastases in Lung May Hide Undiagnosed Primary Lung Cancer
- Early Palliative Care Reduced ICU Use in Patients With Advanced Cancer
- Ginger Extract Raises Antioxidant Levels in Patients Undergoing Chemotherapy
- Nurse Navigators Improve Physician Engagement in Pretreatment Discussions
- Novel Blood Test Detects Cancer, Locates Tumor Without Invasive Procedures
- Screening Increases Early Palliative Care, Reduces Aggressive EOL Measures
- Free Lung Cancer Screening Findings Support Continual Screenings in High-Risk Populations
- Parental Self-persuasion in Low-Income Groups Improves HPV Vaccination Rates
- Discharge Events Improved With Standardized Inpatient Palliative Care Consultation
- Shared Decision-making Visits Improved Comfort With Lung Cancer Screening Decisions
- Temozolomide With Radiotherapy for Glioblastoma Provides Some Survival Benefit in Elderly
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