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EICOSIS: Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain

By Press release submission | Oct 11, 2019

Washington Policy Center analyst says black-market THC products to blame for vaping deaths, illnesses

By Colin Froment | Oct 9, 2019

JANSSEN: Submits Application to U.S. FDA Seeking Approval of STELARA®(ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

By Press release submission | Oct 7, 2019

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HERON THERAPEUTICS: Resubmits New Drug Application to FDA for HTX-011 for the Management of Postoperative Pain

By Press release submission | Oct 1, 2019

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.

U.S. FDA: Approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks

By Press release submission | Sep 26, 2019

The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

U.S. FDA: Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

By Press release submission | Sep 23, 2019

At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications.

RENEO PHARMACEUTICALS: FDA Grants Orphan Drug Designation to Reneo Pharmaceuticals for REN001 for Treatment of Fatty Acid Oxidation Disorders

By Press release submission | Sep 20, 2019

Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).

SOUND PHARMACEUTICALS: FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease

By Press release submission | Sep 19, 2019

Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).

MERCK: FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus

By Press release submission | Sep 18, 2019

Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response

GALA THERAPEUTICS: Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis

By Press release submission | Sep 17, 2019

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOxTM Bronchial RheoplastyTM system.

DREAMED DIABETES: New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy Across All Glucose Measurement Methods

By Press release submission | Sep 17, 2019

DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology

ASTELLAS PHARMA INC.: Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

By Press release submission | Sep 16, 2019

Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020

GBT: Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease

By Press release submission | Sep 8, 2019

Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).

LINEAGE CELL THERAPEUTICS: Announces Issuance of U.S. Patent for Method of Treating Spinal Cord Injury With Stem Cell-Derived Oligodendrocyte Progenitor Cells

By Press release submission | Sep 5, 2019

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,286,009, entitled “Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury” covering methods for utilizing pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) for the treatment of spinal cord injury (SCI).

Sen. Durbin calls for more e-cigarette product regulation from FDA

By Colin Froment | Sep 4, 2019

Following the death of an Illinois citizen who suffered from respiratory illness after vaping, Sen. Dick Durbin (D-IL) sent a letter to the Food and Drug Administration and the Center for Tobacco Products demanding that they remove e-cigarettes and related vaping products off of the market.

U.S. FOOD AND DRUG ADMINISTRATION: Statement calling on all sectors of the papaya industry to improve practices to better protect consumers

By Press release submission | Aug 27, 2019

The U.S. Food and Drug Administration works tirelessly to ensure that foods available to consumers, whether they are produced domestically or abroad, meet the FDA’s food safety requirements and that we are using all available tools to ensure compliance.

SAREPTA THERAPEUTICS: Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application

By Press release submission | Aug 23, 2019

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

VERTEX PHARMACEUTICALS: FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment

By Press release submission | Aug 22, 2019

FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020

CASSIOPEA: Announces FDA Submission of New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years

By Press release submission | Aug 20, 2019

Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.

MODERNA: Receives FDA Fast Track Designation for Zika Vaccine mRNA-1893

By Press release submission | Aug 19, 2019

Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.

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1 RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA

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