MYLAN N.V.: Mylan and Biocon Announce U.S. FDA Approval of Semglee™ (insulin glargine injection)
FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes
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CURIS: Announces FDA Clearance of IND Application for CI-8993, the First-In-Class Monoclonal Anti-VISTA Antibody
Phase 1a/1b dose escalation study to begin in the second half of 2020
F2G LTD: F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
Olorofim is currently in Phase 2b development for the treatment of life-threatening fungal infections
SEKISUI DIAGNOSTICS: Announces FDA Clearance and CLIA Waiver of the OSOM® Ultra Plus Flu A&B Test
High performance, point-of-care rapid test for the detection of Influenza A&B
MOLECULE HOLDINGS: Secures Distribution for FDA/EUA Approved COVID-19 Rapid Antibody Tests
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.
PHOSPHORUS: Announces FDA Approval Of At-Home Saliva Test For COVID-19
Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public Through Web Order
INSMED: Receives FDA Breakthrough Therapy Designation for Brensocatib in Patients with Non-Cystic Fibrosis Bronchiectasis (NCFBE)
Full Results from Phase 2 WILLOW Study of Brensocatib in NCFBE to be Presented at Virtual ATS Session on June 24, 2020
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)
RECARBRIO is Indicated to Treat Multiple Infections Caused by Susceptible Gram-Negative Bacteria in Adults
ABIOMED: FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump
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.
ABBVIE: Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis
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*
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
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
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
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).
AGENUS: FDA Clears IND for iNKT Cells to Treat COVID-19 Patients
AgenTus allogeneic iNKTs have potential to clear SARS-CoV-2 virus & mitigate harmful inflammation
NOCTRIX HEALTH: Granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy
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.
CLARITY PHARMACEUTICALS: Announces that the US FDA Grants Rare Pediatric Disease Designation to 67Cu-SARTATE™ for the Treatment of Neuroblastoma
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.
BAUSCH HEALTH: FDA Provides 510(k) Clearance For BAUSCH + LOMB INFUSE™ Daily Disposable Silicone Hydrogel (SiHy Daily) Contact Lenses
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.
ELIXIRGEN THERAPEUTICS: FDA Approves Elixirgen Therapeutics IND Application for Therapy for Telomere Biology Disorders with Bone Marrow Failure
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.
FDA: Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
The U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
FDA: Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
ELI LILLY AND COMPANY: Lilly's CYRAMZA® (ramucirumab) Receives FDA Approval as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
CYRAMZA, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell lung cancer (NSCLC) with certain activating EGFR mutations, based on the positive global Phase 3 RELAY study