FDA Archives - Page 3 of 220

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Why Microbot Medical Stock Is Up

June 3, 11:36 AM

Microbot Medical shares are trading higher Monday after the company announced that it has received FDA approval to proceed with its human clinical trial as part of its Investigational Device Exemption (IDE) application for its LIBERTY Endovascular Robotic Surgical System.

MBOT

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FDA Expands Approval For Bristol Myers Squibb’s Breyanzi, Making CAR T Cell Therapy Available For Broadest Range Of B-Cell Malignancies

By Vandana Singh

May 31, 2:14 PM

FDA approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) for relapsed or refractory mantle cell lymphoma, marking its fourth non-Hodgkin lymphoma subtype indication.

BMY

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Moderna’s Scores FDA Approval For Its Second Product – Respiratory Syncytial Virus Vaccine

By Vandana Singh

May 31, 1:16 PM

FDA approves Moderna's mRESVIA (mRNA-1345), an mRNA vaccine for RSV, for adults 60+. The second approved mRNA product from Moderna.

MRNA

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FDA Extends Review Deadline For Regeneron/Sanofi’s Dupixent For ‘Smoker’s Lungs’ Disease

By Vandana Singh

May 31, 9:23 AM

The FDA extends the target action date for reviewing Dupixent as an add-on treatment for uncontrolled COPD to September 27, 2024. This follows the submission of additional efficacy analyses from pivotal trials. European Medicines Agency also supports Dupixent for COPD.

REGN

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FDA
News

Castle Biosciences Announces Publication Of Study Demonstrating DecisionDx-SCC Test Identifies High-Risk SCC Patients Benefiting Most From ART

By Benzinga Newsdesk

May 29, 4:32 PM

In the study, patients with DecisionDx-SCC Class 2B test results, predicted to have the highest risk of metastasis by the test, who were treated with adjuvant radiation therapy (ART) had 50% higher metastasis-free survival (MFS) rates, on average, and slowed disease progression compared to Class 2B patients who did not receive ART

CSTL

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FDA Conditionally Approves Eli Lilly’s Thyroid Cancer Drug For Pediatric Patients With Certain Mutations

By Vandana Singh

May 29, 3:02 PM

Accelerated FDA approval for Eli Lilly's selpercatinib (Retevmo) in pediatric patients aged 2+ with advanced/metastatic thyroid cancer & solid tumors carrying RET mutations or fusions.

LLY

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Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca’s Drug

By Vandana Singh

May 29, 12:51 PM

The FDA has approved Amgen's Bkemv as the first interchangeable biosimilar to AstraZeneca's Soliris for treating rare diseases.

AMGN

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FDA Advisory Panel Supports Approval Of Guardant Health’s Blood Test For Colorectal Cancer Screening

By Vandana Singh

May 24, 9:12 AM

FDA panel recommends approval for Guardant Health's Shield blood test for colorectal cancer screening.

2 minute read

What’s Going On With Mid-Cap Cancer-Focused Verastem Oncology Stock On Friday?

By Vandana Singh

May 24, 8:45 AM

Verastem Oncology reports promising initial results from the RAMP 205 trial with an 83% ORR for avutometinib and defactinib in metastatic pancreatic cancer. FDA submission for recurrent KRAS mutant ovarian cancer is underway.

AMGN

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Novo Nordisk’s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review

By Vandana Singh

May 22, 1:21 PM

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will review Novo Nordisk's application for once-weekly insulin icodec on May 24. Concerns include an increased risk of hypoglycemia in type 1 diabetes patients.

NVO