Tuesday, April 8, 2025

Tuesday, April 8, 2025

Latest News

ELIXIRGEN THERAPEUTICS: FDA Approves Elixirgen Therapeutics IND Application for Therapy for Telomere Biology Disorders with Bone Marrow Failure

FDA Approval

By Press release submission | Jun 6, 2020

Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development, and commercialization of therapies for genetic diseases and vaccines, received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its lead candidate, EXG34217, was approved on May 23, 2020. EXG34217 is an autologous cell therapy for telomere biology disorders with bone marrow failure.

BAUSCH HEALTH: FDA Provides 510(k) Clearance For BAUSCH + LOMB INFUSE™ Daily Disposable Silicone Hydrogel (SiHy Daily) Contact Lenses

Reform

By Press release submission | Jun 6, 2020

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for BAUSCH + LOMB INFUSE™ daily disposable silicone hydrogel (SiHy daily) contact lenses.

CLARITY PHARMACEUTICALS: Announces that the US FDA Grants Rare Pediatric Disease Designation to 67Cu-SARTATE™ for the Treatment of Neuroblastoma

FDA Approval

By Press release submission | Jun 6, 2020

Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma.

NOCTRIX HEALTH: Granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy

FDA Approval

By Press release submission | Jun 6, 2020

Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications.

AGENUS: FDA Clears IND for iNKT Cells to Treat COVID-19 Patients

Patients

By Press release submission | Jun 6, 2020

AgenTus allogeneic iNKTs have potential to clear SARS-CoV-2 virus & mitigate harmful inflammation

CELLENKOS® INC.: Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome

Regulation

By Press release submission | Jun 6, 2020

Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS).

SUMITOVANT BIOPHARMA: Announces Myovant Sciences' Submission of New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids

Drug Shortages

By Press release submission | Jun 6, 2020

NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year

ABBVIE: Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis

Patients

By Press release submission | Jun 6, 2020

Submissions supported by two Phase 3 studies in which RINVOQ demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo*

ABIOMED: FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump

FDA Approval

By Press release submission | Jun 8, 2020

The US FDA has approved Abiomed’s first-in-human trial of the Impella ECP, a temporary percutaneous heart pump that expands once inside the body, allowing for a smaller access site. Read more about the ECP and Abiomed’s early feasibility study.

MERCK: FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

FDA Approval

By Press release submission | Jun 8, 2020

RECARBRIO is Indicated to Treat Multiple Infections Caused by Susceptible Gram-Negative Bacteria in Adults

INSMED: Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)

Reform

By Press release submission | Jun 9, 2020

Full Results from Phase 2 WILLOW Study of Brensocatib in NCFBE to be Presented at Virtual ATS Session on June 24, 2020

PHOSPHORUS: Announces FDA Approval Of At-Home Saliva Test For COVID-19

FDA Approval

By Press release submission | Jun 9, 2020

Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public Through Web Order

MOLECULE HOLDINGS: Secures Distribution for FDA/EUA Approved COVID-19 Rapid Antibody Tests

FDA Approval

By Press release submission | Jun 10, 2020

In the initial scramble to quell the impact of the COVID-19 pandemic, the rapid antibody test market was been flooded. Not all tests are created equal and the COVID-19 crisis introduced the opportunity to try unproven players in rapid diagnostic testing.

SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the OSOM® Ultra Plus Flu A&B Test

FDA Approval

By Press release submission | Jun 10, 2020

High performance, point-of-care rapid test for the detection of Influenza A&B

F2G LTD: F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections

Patients

By Press release submission | Jun 11, 2020

Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections

CURIS: Announces FDA Clearance of IND Application for CI-8993, the First-In-Class Monoclonal Anti-VISTA Antibody

Regulation

By Press release submission | Jun 11, 2020

Phase 1a/1b dose escalation study to begin in the second half of 2020

MYLAN N.V.: Mylan and Biocon Announce U.S. FDA Approval of Semglee™ (insulin glargine injection)

FDA Approval

By Press release submission | Jun 12, 2020

FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes

GENEQUANTUM HEALTHCARE: World's first iLDC enabling ADC drug receives IND clearance by the US FDA

FDA Approval

By Press release submission | Jun 12, 2020

GeneQuantum Healthcare (GQ) has recently received the US IND approval for its in-house developed next generation antibody drug conjugate (ADC) asset, GQ1001.

FDA: Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease

FDA Approval

By Press release submission | Jun 17, 2020

The U.S. Food and Drug Administration approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

FDA: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test

Regulation

By Press release submission | Jun 17, 2020

The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

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