fda | Media Room | PressRelease.com

- Xyngari (formerly DMT310) is currently being studied in Phase 3 for the treatment of acne, with topline results from the first Phase 3 STAR-1 study expected in March 2025 -

Press Release Dec 10, 2024

DEA Continues to Block MMJ Marijuana Drug Development for Neurological Disorder

MMJ Submits FDA Investigational New Drug Application for Cannabis-Derived Drug

Press Release Dec 10, 2024

MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End

Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain

Press Release Nov 20, 2024

MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site

Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment

Press Release Nov 5, 2024

AMC Health Receives Expanded FDA Clearance for Advanced Virtual Care and Risk Prediction Technology

Predicated on an unrivaled trove of millions of data points amassed over 20 years, these AI tools accurately predict near-term risk of ED, all-cause hospitalization, or death sans mitigation. Read More

Press Release Oct 28, 2024

MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain

Press Release Oct 21, 2024

MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study

Press Release Sep 27, 2024

MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024

Press Release Sep 24, 2024

Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to Be Conducted in the United States

Press Release Sep 18, 2024

MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025

Press Release Sep 11, 2024

MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA

Press Release Sep 9, 2024

CELLTech(TM) DBS: Your Brain’s Healing Power Under Your Control

Press Release Sep 3, 2024

Lyme ImmunoBlot Receives FDA Clearance

Newly Cleared Technology is a Game Changer for the Diagnosis of an Often Debilitating Disease Read More

Press Release Aug 22, 2024

Neurocare Group Receives FDA Clearance for Its Industry-Leading Intermittent Theta Burst Stimulation (iTBS) Protocol for Transcranial Magnetic Stimulation (TMS)

neurocare is pleased to announce that it has received FDA clearance for its industry-leading intermittent Theta Burst Stimulation (iTBS) protocol, available across its Apollo TMS Therapy System and other Transcranial Magnetic Stimulation systems for clinical practice. Read More

Press Release Aug 15, 2024

ASTCT Applauds FDA Approval of Axatilimab-Csfr for the Treatment of Chronic Graft-Versus-Host Disease (cGVHD)

Press Release Aug 2, 2024

American Society for Transplantation and Cellular Therapy Applauds FDA Approval of TECELRA® for Synovial Sarcoma Treatment

Press Release Aug 2, 2024

Biden-Harris-DEA Marijuana Scam - MMJ's Legal Actions Proceed in Federal Court

DEA SUMMONS HAVE BEEN SERVED

Summons have been served on DEA officials, the Attorney General and the Administrative Law Judge to appear in Rhode Island federal court on MMJ's complaint.

Press Release Jul 16, 2024

Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health

Press Release Jul 8, 2024

Amin Wasserman Gurnani Welcomes Former Acting Director for FDA’s Office of Dietary Supplement Programs as Co-Chair of the Firm’s Regulatory Group

Robert “Bob” Durkin to co-lead regulatory practice with partner Rend Al-Mondhiry Read More

Press Release Jun 27, 2024

Neuro20 Sparks Hope for Long COVID Recovery

White Paper discussing patient improvements and potential mechanisms for patients with Long COVID. Read More

Press Release May 20, 2024

Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations

h2o Announces FDA Listing of Apple Watch-Based Cueing Feature 'Foggy' for Freezing of Gait in Parkinson’s Disease

Press Release Apr 11, 2024

Amid FDA Concerns, HTL-Strefa Inc. Offers a Reliable and Safe Alternative to Chinese Supplied Needles & Syringes With European-Produced Sicura™ Passive Safety Needle

DropSafe® Sicura™ is the first and only fully passive safety needle in North America. Sicura™ designed to eliminate needlestick injuries, providing a safe injection experience, and is distributed by HTL-Strefa Inc., an MTD company. Read More

Press Release Mar 22, 2024

Amid FDA Concerns of Chinese Supplied Needles & Syringes, HTL-Strefa Inc. Offers a Reliable and Safe Alternative With Its European-Produced Passive Safety Needle, Sicura TM

DropSafe® Sicura™ is the first and only fully passive safety needle in North America. Sicura™ is designed to eliminate needlestick injuries, providing a safe injection experience, and is distributed by HTL-Strefa Inc., an MTD company. Read More

Press Release Mar 13, 2024

Statement by Fragrance Creators Association on Funding to Support Implementation of the Modernization of Cosmetics Regulation Act

Press Release Mar 1, 2024

Advocacy Groups Join Reagan-Udall Foundation and FDA for Workshop on Developing Biomarkers to Support Accelerated Approval in Rare Diseases

Workshop Presented Overwhelming Scientific Evidence to Support CSF-HS as a Primary Biomarker in Neuropathic MPS Disorders Read More

Press Release Feb 27, 2024

Droice Labs Discusses SuperLineage for Real-World Data Traceability at FDA Listening Session

Press Release Feb 19, 2024

ASTCT Supports the FDA’s Accelerated Approval of AMTAGVI for Treatment of Metastatic Melanoma

Press Release Feb 8, 2024

CorDx is Expected to Launch Groundbreaking 10-Minute Solution for Distinguishing COVID-19 and Flu A/B as Respiratory Cases Surge Across the U.S.

ZetrOZ Systems’ sam 2.0 Wearable Ultrasound Unit Receives New FDA Clearance for Expanded Medical Indications

Press Release Jan 9, 2024

Fragrance Creators Association Congratulates Dr. Namandjé Bumpus on Her Promotion to Principal Deputy Commissioner at FDA

Press Release Nov 16, 2023

Dermata to Begin Enrolling Patients in DMT310 Phase 3 Acne Clinical Program in December 2023 based on Agreement with FDA on the Phase 3 Protocols

Press Release Oct 26, 2023

Dermata Therapeutics Completes Start-Up Activities to Support DMT310 Phase 3 STAR-1 Acne Trial

Press Release Sep 8, 2023

MMJ Positioned To Win DEA Lawsuit As HHS Verifies Marijuana Has Medical Benefit To Patients

Press Release Aug 14, 2023

Lactiga Receives FDA 'Rare Pediatric Disease' Designation for Groundbreaking Mucosal Immunoglobulin Therapy for Common Variable Immunodeficiency Disease

LCTG-001 on course to be the first FDA-approved biologic from human milk Read More

Press Release Aug 8, 2023

Dermata Therapeutics Announces Positive Feedback from FDA on the DMT310 Phase 3 Clinical Development Program in Moderate-to-Severe Acne

Press Release Jun 23, 2023

Vapor Technology Association Issues Statement Criticizing FDA 'Inspection Blitz' Announcement

Vapor Trade Group Warns Against What It Says Is FDA Misinformation That Jeopardizes Harm Reduction Mission Read More

Press Release Jun 23, 2023

Statement by Fragrance Creators' President & CEO, Farah K. Ahmed, on Congress' Support of Funding for the Modernization of Cosmetics Regulation Act

Press Release Jun 12, 2023

Belhaven Biopharma Announces Positive Data From Their Nasdepi(R) Dose Confirmation Study in Patients With and Without Allergic Rhinitis

Marti Law Group Files Amicus Brief on Behalf of NP2Go in Federal Suit Challenging FDA’s Removal of Semaglutide From Drug Shortage List

MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain

Green Leaf Innovations, Inc. Celebrates Landmark U.S. Court of Appeals Ruling on FDA Regulation of Premium Cigars

The Man Behind The DEA Federal Marijuana Scam-Meet Matt Strait-He Defied Presidential Mandates For Research

Repair Biotechnologies Announces Positive Pre-IND Meeting With FDA for REP-0003 to Treat Homozygous Familial Hypercholesterolemia

Dermata and Revance Enter Clinical Trial Collaboration Agreement for the Topical Application of Xyngari(TM) with Daxxify(R)

Merick Garland, DEA Director Anne Milgram, Al Judge Under Federal Court Summons Over DEA Failed Marijuana Policy

MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development

Dermata Receives Approval from FDA for the Proprietary Name Xyngari(TM)

DEA Continues to Block MMJ Marijuana Drug Development for Neurological Disorder

MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End

MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site

AMC Health Receives Expanded FDA Clearance for Advanced Virtual Care and Risk Prediction Technology

MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain

MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study

MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024

Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to Be Conducted in the United States

MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025

MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA

CELLTech(TM) DBS: Your Brain’s Healing Power Under Your Control

Lyme ImmunoBlot Receives FDA Clearance

Neurocare Group Receives FDA Clearance for Its Industry-Leading Intermittent Theta Burst Stimulation (iTBS) Protocol for Transcranial Magnetic Stimulation (TMS)

ASTCT Applauds FDA Approval of Axatilimab-Csfr for the Treatment of Chronic Graft-Versus-Host Disease (cGVHD)

American Society for Transplantation and Cellular Therapy Applauds FDA Approval of TECELRA® for Synovial Sarcoma Treatment

Biden-Harris-DEA Marijuana Scam - MMJ's Legal Actions Proceed in Federal Court

Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health

Amin Wasserman Gurnani Welcomes Former Acting Director for FDA’s Office of Dietary Supplement Programs as Co-Chair of the Firm’s Regulatory Group

Neuro20 Sparks Hope for Long COVID Recovery

Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations

h2o Announces FDA Listing of Apple Watch-Based Cueing Feature 'Foggy' for Freezing of Gait in Parkinson’s Disease

ASTCT Supports the FDA’s Approval of Earlier Use of CAR T-Cell Therapy for Multiple Myeloma

Pace® Life Sciences Announces Successful Outcomes Following US FDA Inspection of Operations in San German, Puerto Rico

CorDx Receives Emergency Use Authorization (EUA) for 10-Min Flu A/B & COVID-19 Test

Amid FDA Concerns, HTL-Strefa Inc. Offers a Reliable and Safe Alternative to Chinese Supplied Needles & Syringes With European-Produced Sicura™ Passive Safety Needle

Amid FDA Concerns of Chinese Supplied Needles & Syringes, HTL-Strefa Inc. Offers a Reliable and Safe Alternative With Its European-Produced Passive Safety Needle, Sicura TM

Statement by Fragrance Creators Association on Funding to Support Implementation of the Modernization of Cosmetics Regulation Act

Advocacy Groups Join Reagan-Udall Foundation and FDA for Workshop on Developing Biomarkers to Support Accelerated Approval in Rare Diseases

Droice Labs Discusses SuperLineage for Real-World Data Traceability at FDA Listening Session

ASTCT Supports the FDA’s Accelerated Approval of AMTAGVI for Treatment of Metastatic Melanoma

CorDx is Expected to Launch Groundbreaking 10-Minute Solution for Distinguishing COVID-19 and Flu A/B as Respiratory Cases Surge Across the U.S.

ZetrOZ Systems’ sam 2.0 Wearable Ultrasound Unit Receives New FDA Clearance for Expanded Medical Indications

Dermata Enrolls First Patient in Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne

ASTCT Response to FDA Approval of Gene Therapies for Treatment of Sickle Cell Disease (SCD)

Statement by Fragrance Creators' President & CEO on GAO Cosmetic Safety Report

New Facility to Drive Growth and Employment for the City of Independence

Fragrance Creators Association Congratulates Dr. Namandjé Bumpus on Her Promotion to Principal Deputy Commissioner at FDA

Dermata to Begin Enrolling Patients in DMT310 Phase 3 Acne Clinical Program in December 2023 based on Agreement with FDA on the Phase 3 Protocols

Dermata Therapeutics Completes Start-Up Activities to Support DMT310 Phase 3 STAR-1 Acne Trial

MMJ Positioned To Win DEA Lawsuit As HHS Verifies Marijuana Has Medical Benefit To Patients

Lactiga Receives FDA 'Rare Pediatric Disease' Designation for Groundbreaking Mucosal Immunoglobulin Therapy for Common Variable Immunodeficiency Disease

DEA Delays MMJ Company Marijuana Research, Clinical Trials and Pharma Development as Patients Suffer

MMJ Prepares DEA Marijuana Lawsuit - DEA Violated Presidential Research Expansion Act and Congressional Mandates

ForCast Orthopedics Receives Orphan Drug Designation From FDA for the Treatment of Periprosthetic Joint Infection (PJI)

Dermata Therapeutics Announces Positive Feedback from FDA on the DMT310 Phase 3 Clinical Development Program in Moderate-to-Severe Acne

Vapor Technology Association Issues Statement Criticizing FDA 'Inspection Blitz' Announcement

Statement by Fragrance Creators' President & CEO, Farah K. Ahmed, on Congress' Support of Funding for the Modernization of Cosmetics Regulation Act

Neobiosis Announces FDA Approval of IND for Use of ViXomeTM in COVID-19 'Post Covid Syndrome'

ForCast Orthopedics Receives QIDP Designation From FDA

Dermata Therapeutics Provides Corporate Update and Reports First Quarter 2023 Financial Results