Sunday, February 16, 2020

Sunday, February 16, 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.

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Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”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

U.S. FDA: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.

U.S. FDA: Statement on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions

ABBOTT: Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease

Abbott's Infinity™ DBS is the first FDA approved directional Deep Brain Stimulation (DBS) system to allow targeting of a specific area of the brain that is critical to motor functions

U.S. FDA: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).

U.S. FDA: FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

U.S. Food and Drug Administration is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.

ARUVANT: Receives Orphan Drug Designation for ARU-1801 for the Treatment of Sickle Cell Disease

ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and β-thalassemia

INHIBITOR THERAPEUTICS: Receives prostate cancer IND Clearance from FDA

SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer

OBI PHARMA: Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

Second Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate in combination with a validated payload (MMAE) and the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.

FDA Health News