Wednesday, April 1, 2020

Wednesday, April 1, 2020

Latest News

U.S. FDA: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts.

ASTEX PHARMACEUTICALS: Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.

MEDICREA: Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.

PLASMOLOGY4: FDA Grants Plasmology4® "Breakthrough Device Designation" for the Treatment of Multidrug-Refractory Bacteria

Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company's product has been granted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program for the treatment of "multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed."

JANSSEN ONCOLOGY: Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting

KLEO PHARMACEUTICALS: Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic

KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients

COGNITA LABS, LLC: 90% of Patients Can't Use Inhalers Correctly, Digital Inhaler CapMedic Receives FDA Clearance to Change That

Cognita Labs, a respiratory technologies company, announced U.S. Food and Drug Administration (FDA) clearance for CapMedic, world's first interactive digital inhaler sensor for asthma, Chronic Obstructive Pulmonary Disease (COPD) and other pulmonary conditions.

PHARMACOSMOS THERAPEUTICS INC.: Monoferric® (ferric derisomaltose) injection is approved by the US FDA for the treatment of iron deficiency anemia

Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.

VIZIENT: Comments Support FDA’s Efforts to Expedite Biosimilar Insulin Development

Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”

ARREVUS: Receives FDA Qualified Infectious Disease Product (QIDP) Designation for the Treatment of Cystic Fibrosis Pulmonary Exacerbations

Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.

TEVA: Announces FDA Approval of AJOVY® (fremanezumab-vfrm) Injection Autoinjector

Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.

U.S. FDA: FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.

TUBEROUS SCLEROSIS ALLIANCE: Lauds Lundbeck And FDA For Sabril Label Expansion For Patients 2 To 10 Years Old

On January 24, the Tuberous Sclerosis Alliance (TS Alliance) learned the US Food and Drug Administration (FDA) formally approved Lundbeck Pharmaceutical's label expansion for Sabril® (vigabatrin) to now be available to treat refractory complex partial seizures in patients 2 to 10 years old.

ELI LILLY AND COMPANY: US FDA approves only triple-combination tablet with Jardiance® for adults with type 2 diabetes

Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) is a once-daily therapy combining three well-established treatments in one pill

FDA Health News