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EISAI INC.: U.S. FDA Approves Eisai's DAYVIGO™ (lemborexant) for the Treatment of Insomnia in Adult Patients
Approval Based on Robust Clinical Development Program That Included Two Pivotal Trials of Nearly 2,000 Patients
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BIOMARIN: Submits Biologics License Application to U.S. Food and Drug Administration for Valoctocogene Roxaparvovec to Treat Hemophilia A
1st Marketing Application Submission in U.S. for Gene Therapy Directed at Any Type of Hemophilia
U.S. FDA: FDA approves new treatment for adults with migraine
The U.S. Food and Drug Administration approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.
U.S. FDA: FDA approves first generics of Eliquis
U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
OBI PHARMA: Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types
SEATTLE GENETICS: Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Submission Based on Positive Pivotal HER2CLIMB Trial Results Recently Presented at the 2019 San Antonio Breast Cancer Symposium and Published in the New England Journal of Medicine
MERCK: LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer
LYNPARZA Reduced the Risk of Disease Progression or Death by 47% Compared to Placebo in Patients Whose Disease Had Not Progressed On at Least 16 Weeks of a First-Line Platinum-Based Chemotherapy Regimen. Only PARP Inhibitor Approved in Germline BRCA-mutated Advanced Pancreatic Cancer
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U.S. FDA: Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation
Outbreaks declared over, investigation advances, root cause analysis continues
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TENNOR THERAPEUTICS: Received FDA Orphan Drug Designation
TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.
U.S. FDA: FDA approves first treatment for thyroid eye disease
U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).
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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.
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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
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
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.
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).
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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
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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
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.
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
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.