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FDA In Brief: FDA Announces Investigations of Two Outbreaks of E. coli O157:H7 Illnesses

The FDA, along with the CDC and our state and local partners, are working to investigate two outbreaks of Shiga toxin-producing E. coli O157:H7 (STEC) illnesses.

AMGEN: Announces Participation Of Systemic Lupus Erythematosus (SLE) Adaptive Clinical Trial In The FDA Complex Innovative Trial Designs (CID) Pilot Program

Amgen and FDA Collaborate on Novel Clinical Trial Design to Advance Development of Potential Treatment for Patients With Uncontrolled SLE

JANSSEN: Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease

Application seeks approval of XARELTO® plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD)

SANTEN: Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Cyclosporine Topical Ophthalmic Emulsion, 0.1% for the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18

Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18.

AEGLE THERAPEUTICS: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for AGLE-102 for Patients with Dystrophic Epidermolysis Bullosa

Aegle Therapeutics Corporation, a first-in-class biotechnology company committed to delivering cell-free therapy to patients affected by severe dermatological conditions, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation to AGLE-102™ for the treatment of dystrophic epidermolysis bullosa (DEB), a skin blistering disorder.

CARSGEN THERAPEUTICS: Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers

CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that the United States (US) Food and Drug Administration (FDA) has granted orphan drug designation to one of CARsgen's first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma.

AEGLE THERAPEUTICS CORPORATION: FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa

Aegle Therapeutics Corporation today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AGLE-102™ for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.

INNOVA THERAPEUTICS: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for IVT-8086 for the Treatment of Osteosarcoma

Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, today announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2

LEAP THERAPEUTICS: Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer

Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.

LUNGEVITY: Launches Lung Cancer Patient Research Project in Collaboration with the FDA

The new multi-year study will seek to understand different aspects of the patient experience with lung cancer to improve treatment options and outcomes

MASIMO: PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients

Masimo (NASDAQ: MASI) announced that PVi® has received FDA clearance as a continuous, noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

SCHOLAR ROCK: Announces that SRK-015 has Received Rare Pediatric Disease Designation from U.S. FDA for the Treatment of Spinal Muscular Atrophy

Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for SRK-015 for the treatment of Spinal Muscular Atrophy (SMA), a progressive, rare genetic disease that leads to motor function impairments.

FDA: Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

The U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.

ANIXA BIOSCIENCES: Breast Cancer Vaccine Technology Nearing FDA Submission

Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced that its prophylactic breast cancer vaccine is making progress towards clinical trials.

FDA Health News