FDA Archives - Page 45 of 220

1 minute read

Investor Caution – Medtronic’s Rocky Road Ahead For Hypertension Device

August 24, 2:20 PM

The FDA Circulatory System Devices Panel vote was closely divided on the benefit/risk profile of Medtronic Plc's (NYSE: MDT) device (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote, recommending against the approval of the blood pressure treat

MDT

2 minute read

Tarsus Pharmaceuticals, Inc. Announces That XDEMVY 0.25% Is Now Available At Pharmacies Nationwide For Prescription. The U.S. FDA Approved Drug On July 24, 2023, For The Treatment Of Demodex Blepharitis

By Happy Mohamed

August 24, 9:11 AM

Demodex blepharitis impacts approximately 25 million eye care patients in the U.S. – or 1 out of every 12 adults. XDEMVY is indicated for all adult patients with Demodex blepharitis and is available via

TARS

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Regulatory Setback For Medtronic’s High Blood Pressure Device – FDA Backed Japanese Firms’ Similar Device For Uncontrolled Hypertension

By Vandana Singh

August 24, 8:45 AM

Medtronic Plc (NYSE: MDT) says the FDA Circulatory System Devices Panel (CSDP) voted unanimously (13-0) on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure,

MDT

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Individuals With Uncontrolled Hypertension – FDA Adcomm Panel Just Supported Japanese MedTech’s Blood Pressure Treatment Device

By Vandana Singh

August 23, 9:34 AM

The FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee backed Recor Medical Inc and its parent company, Otsuka Medical Devices Co Ltd's</

OTSKF

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U.S. Food and Drug Administration Approves Orphan Drug Designation For Immix Biopharma NXC-201 As A Treatment For Multiple Myeloma

By Happy Mohamed

August 23, 8:39 AM

FDA Orphan Drug Designation ("ODD") qualifies NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testing Waiver of the Prescription Drug User Fee (currently

IMMX

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Organovo Advances Clinical Timelines For FXR314 And Provides Updates On NASH Phase 2 Data

By Benzinga Newsdesk

August 23, 8:06 AM

Organovo Holdings, Inc.

ONVO

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Why Is Fulcrum Therapeutics Stock Surging Today?

By Vandana Singh

August 22, 11:05 AM

Fulcrum Therapeutics Inc (NASDAQ: FULC) shares are trading higher after the FDA lifted the clinical hold on the Investigational New Drug (IND) application for FTX-6058 for the potential treatment of

FULC

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‘Standing Recommendations For Mpox Issued By The Director-General Of The World Health Organization In Accordance With The International Health Regulations’

By Happy Mohamed

August 22, 10:51 AM

https://www.who.int/publications/m/item/standing-recommendations-for-mpox-issued-by-the-director-general-of-the-world-health-organization-(who)-in-accordance-with-the-international-health-regulations-(2005)-(ihr) The

GOVX

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FDA Greenlights Pfizer’s RSV Vaccine: Moms Can Now Protect Babies Before Birth

By Vandana Singh

August 22, 9:28 AM

Monday, the FDA approved Pfizer Inc's (NYSE: PFE) Abrysvo (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, to prevent the infection in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through <

AZN

2 minute read

Regeneron’s Crucial Eylea HD Approval: A Shield Against Potential Biosimilar Competition?

By Vandana Singh

August 21, 3:04 PM

Friday, the FDA approved Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) approved Eylea HD (aflibercept) Injection 8 mg for wet age-related macular degeneration, diabetic macular edema,

REGN