FDA Archives - Page 9 of 220

3 minute read

U.S. FDA Approves Bristol Myers Squibb And 2seventy bio’s Abecma For Triple-Class Exposed Relapsed Or Refractory Multiple Myeloma After Two Prior Lines Of Therapy; Abecma Tripled Progression-Free Survival Compared To Standard Regimens In The Phase 3 Ka…

April 5, 9:07 AM

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profileExpanded approval

BMY

3 minute read

Caribou Biosciences Expands Clinical Development Of CB-010 With FDA Clearance Of IND In Lupus

By Benzinga Newsdesk

April 4, 4:01 PM

-- FDA has cleared Caribou's IND application for CB-010 in lupus nephritis and extrarenal lupus; GALLOP Phase 1 clinical trial expected to initiate by YE 2024 -- -- Driven by encouraging initial safety and efficacy

CRBU

1 minute read

FDA
News

Nexalin Technology Awarded Key Patent Related To Gen-3 HALO Clarity

By Benzinga Newsdesk

April 4, 1:12 PM

Mark White, CEO of Nexalin Technology, stated, "This method of use patent award marks a major achievement for the Company and follows another recent patent covering our core technology. These patents extend through 2040

NXL

2 minute read

Medical Devices Focused AngioDynamics Unveils Upbeat 2024 Financial Outlook, Stock Soars

By Vandana Singh

April 4, 12:53 PM

FDA grants 510(k) clearance to AngioDynamics' AlphaVac F1885 System for pulmonary embolism. Expanded indication broadens treatment options. Sales slightly below consensus, but pro forma basis sees growth.

ANGO

3 minute read

iECURE Announces FDA Clearance Of IND Application For ECUR-506 To Initiate OTC-HOPE Trial For Treatment Of Neonatal Onset Ornithine Transcarbamylase Deficiency In The U.S.; NOTE: iECURE Has Licensed The ARCUS Nuclease For ECUR-506 From Precision BioSci…

By Benzinga Newsdesk

April 4, 11:02 AM

Clinical trial sites in the United States, United Kingdom, and Australia will evaluate ECUR-506, an investigational gene editing-based therapy, in newborn males with neonatal onset Ornithine Transcarbamylase (OTC)

DTIL

2 minute read

FDA
News

Simulations Plus Announces U.S. FDA Renews DILIsym Software Licenses For 7th Year

By Benzinga Newsdesk

April 4, 8:35 AM

Predicting DILI risk supports informed decision-making regarding drug evaluations and approvalsSimulations Plus, Inc. (NASDAQ:SLP), a leading provider of modeling and simulation solutions for the pharmaceutical,

SLP

2 minute read

Why Is Vanda Pharmaceuticals Stock Trading Higher Today?

By Vandana Singh

April 3, 8:48 AM

FDA approves Vanda Pharmaceuticals' Fanapt tablets for bipolar I disorder manic or mixed episodes in adults. Fanapt, an atypical antipsychotic, shows significant improvement over placebo in pivotal study.

VNDA

2 minute read

Biden Government Again Missed Menthol Cigarettes Ban Deadline, Lawsuit Challenges FDA’s Delay

By Vandana Singh

April 2, 2:56 PM

Facing delays, the FDA's proposal to ban menthol cigarettes in the US encounters setbacks as White House officials miss yet another deadline. Industry giants like Altria and British American Tobacco face uncertainty as calls to enforce the ban intensify.

BTI

2 minute read

What’s Going With COVID-19 Test Maker QuidelOrtho Stock On Tuesday?

By Vandana Singh

April 2, 1:05 PM

QuidelOrtho secures FDA approval for QuickVue COVID-19 test, catering to home and medical settings. Despite Savanna RVP4+ assay withdrawal, company promises a new multiplex assay for 2024/2025 respiratory season.

QDEL

2 minute read

FDA Approves Abbott’s Heart Valve Repair Device For Patients At Risk Of Complications/Death During Open-Heart Surgeries

By Vandana Singh

April 2, 1:00 PM

FDA approves Abbott Laboratories' TriClip TEER system for treating tricuspid regurgitation. Clip technology offers non-invasive repair, fast recovery, and significant improvement in quality of life. Already approved in 50+ countries

ABT