FDA Approvals

FDA Approvals

FDA Clears IND Application for CAR-Natural Killer Cell Therapy to Treat B-Cell Malignancies

The FDA cleared an investigational new drug application for NKX019, a chimeric antigen receptor-natural killer cell therapy for patients with R/R B-cell malignancies.

FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer

The FDA approves pembrolizumab in combination with trastuzumab plus fluoropyrimidine- and platinum-containing CT for the first-line treatment of patients with locally advanced unresectable or metas

The ASCO Post
FDA Panel Votes Against Two Cancer Indications But Backs 4 of 6


The staff of the FDA will now consider these votes as they decide what to do regarding the six cases of what they have termed "dangling" accelerated approvals.


FDA Grants Breakthrough Therapy Designation to Asciminib for CML

The FDA has granted breakthrough therapy designation to asciminib for the treatment of adults with Philadelphia chromosome-positive chronic-phase CML that is resistant to...

ASH Clinical News
FDA ODAC Votes in Favor of Maintaining Accelerated Approval of Atezolizumab/Nab-paclitaxel for PD-L1–Positive, Metastatic Triple-Negative Breast Cancer

The FDA ODAC voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with CT for the treatment of adults with unresectable locally advanced or metastatic TNBC

The ASCO Post
FDA Approves Loncastuximab for Diffuse Large B-Cell Lymphomas

The FDA grants an accelerated approval for a new drug for use in patients with R/R DLBCL who have tried at least two prior systemic therapies.

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer

The FDA approved nivolumab as part of combination therapy for certain patients with gastrointestinal malignancies.

FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer

The FDA granted accelerated approval to sacituzumab govitecan-hziy for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing CT and...

The ASCO Post
CAR-T Therapy Is Approved for Non-Hodgkin Lymphoma

Lisocabtagene maraleucel is a CAR-T therapy indicated for patients who haven’t responded to or have relapsed after at least 2 other systemic treatments.

JAMA Network
FDA Updates Highlighting the Latest Cancer Treatments

Oncology Times covers the most recent FDA approvals in cancer treatment.

Oncology Times - Latest Articles
FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma

The FDA has approved pembrolizumab in combination with platinum and fluoropyrimidine-based CT for patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma...

The ASCO Post
FDA Updates Highlighting the Latest Cancer Treatments

The latest developments in FDA approvals for cancer treatments.

Oncology Times - Latest Articles
FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval

These products are being used under accelerated approval to treat patients with breast, urothelial, gastric, and hepatocellular cancers.

The ASCO Post
FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma

The FDA just granted accelerated approval to Pepaxto in combination with dexamethasone for adult patients with R/R multiple myeloma who have received at least four prior lines of therapy...

The ASCO Post
FDA OKs New CAR T- Cell Tx for Large B-cell Lymphomas

The FDA has approved lisocabtagene maraleucel (Breyanzi), a CAR T-cell product for the treatment of adults with certain types of R/R large B-cell lymphoma who relapse or...

FDA Updates Highlighting the Latest Cancer Treatments

Read more about the FDA's latest updates in cancer treatment.

Oncology Times - Latest Articles
FDA Updates Highlighting the Latest Cancer Treatments

The FDA approved margetuximab-cmkb in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received...

Oncology Times - Latest Articles
FDA Approves First and Only Treatment for AL Amyloidosis

The first and only treatment for a rare and often fatal blood cell disorder has been approved in the United States.

FDA Approval of Immunotherapy Drugs Brings Hope to Mesothelioma Patients

The drugs—nivolumab and ipilimumab—have now been approved by the FDA for first-line treatment of adult patients who suffer from malignant pleural mesothelioma.

Oncology Times - Latest Articles
The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors

This methodological review compared the quality of reporting of safety information and in particular, serious irAEs, in publications and ClinicalTrials.gov for all current FDA-approved ICIs.

BMC Cancer
FOCR Meeting Highlights Modernization of Expedited FDA Drug Approvals

The Friends of Cancer Research held the first of a two-part virtual annual meeting, which focused on ways of updating expedited drug approvals at the FDA.

Oncology Times - Latest Articles
A New Strategy in Treating Patients With CAR T-Cell Therapy

A novel “switchable” CAR T-cell therapy for blood cancers moved into early clinical trials recently after gaining Fast Track designation from the FDA. 

Oncology Times - Latest Articles
FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis.

This study examines new drug approvals for breast cancer by the FDA and the EMA, based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018.

The economic consequences of US FDA new drug approvals: evidence from Taiwan pharmaceutical and biotech companies

This study examines the association between new drug approvals released by US Food and Drug Administration (FDA) subsequent market stock price reactions for listed pharmaceutical bi......

Innovation-the European Journal of Social Science Research
Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.

The aim of this study is to compare FDA Accelerated vs Regular Pathway approvals and BTD for lung cancer treatments between 2006 and 2018 regarding...

Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA's Benefit-Risk Framework to Calculate Net-Benefit Score and Benefit-Risk Ratio.

Approval of regulated medical products in the USA is based upon a rigorous review benefits and risks as performed by US FDA staff scientists summarized descriptive qualitative format called...

Therapeutic Innovation &amp
FDA Approvals and Consensus Guidelines for Botulinum Toxins in the Treatment of Dystonia.

In 2016, the American Academy of Neurology (AAN) published practice guidelines for botulinum toxin (BoNT) in treatment blepharospasm, cervical dystonia, adult spasticity, and headache.

FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals.

Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs biologics.

Therapeutic Innovation &amp
2019 in review: FDA approvals of new medicines.

53 146 2018 The US Food and Drug Administration (FDA) green-lighted the marketing of therapeutic agents in 2019. This rate approvals was consistent with 5-year running average.

Drug Discovery Today

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