Latest News
RENETX BIO, INC.: Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury
ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company's Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204.
Questions raised over cancer drugs in FDA's accelerated approval program
WASHINGTON -- A low percentage of cancer drugs that received accelerated Food and Drug Administration approval had positive results in the long run, according to a recent study by the Journal of the American Medical Association.
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TORQUE: FDA Grants Fast Track Designation for Torque's First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501
Torque, a clinical-stage immuno-oncology company developing Deep-Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque's first Deep-Primed™ T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells).
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for pediatric patients with type 2 diabetes
The U.S. Food and Drug Administration approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes.
Effectiveness of fast-tracked cancer drugs questioned
Few cancer drugs that received accelerated Food and Drug Administration approval lived up to their billing, according to a JAMA study.
MERCK: FDA Approves Two New Indications for Merck’s KEYTRUDA® (pembrolizumab)
KEYTRUDA Now Approved for First-Line Treatment of Patients with Metastatic or with Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma as Monotherapy for Patients Whose Tumors Express PD-L1 (CPS ≥1) or in Combination with Platinum and Fluorouracil (FU) Regardless of PD-L1 Expression
IVENIX, INC.: Ivenix Infusion System Receives FDA 510(k) Clearance; Poised to Revolutionize the Infusion Pump Industry
Aimed at reducing medication errors and related healthcare costs, Ivenix prepares to bring its infusion system to the $4.7 billion North American infusion market
FDA Update: May medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
ALS advocates considering ACT UP’s take-no-prisoners approach
Today, a group of ALS patients will come together to protest at the Food and Drug Administration building in Maryland to say they have not seen a response in research from the $115 million raised globally from the ice bucket challenge.
Device may offer relief to teens with irritable bowel syndrome
The IB-Stim would be used in combination with other IBS therapies.
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GENENTECH: FDA Grants Priority Review to Genentech’s Rituxan (Rituximab) in Children with Two Rare Blood Vessel Disorders
Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis
CERTARA: Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug
In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA AND
BOLDER BIOTECHNOLOGY: Announces FDA Orphan Drug Designation for BBT-059 for Acute Radiation Syndrome
Bolder BioTechnology, Inc. announced that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug Administration for treatment of Acute Radiation Syndrome (ARS).
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APPLIED BIOCODE, INC.: Obtains FDA Clearance of the Roche MagNA Pure 96 Extraction System for its Gastrointestinal Pathogen Panel
Applied BioCode announced that it has received U.S. Food and Drug Administration 510(k) clearance for the use of the Roche MagNA Pure 96* Extraction System with the high throughput BioCode® MDx-3000 and Gastrointestinal Pathogen Panel (GPP).
FDA should 'err on the side of caution' with forever chemicals
A public health watch dog warns that the presence of “forever chemicals” in foods recently tested by the Food and Drug Administration should be treated with alarm.
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SPEEDX: Receives FDA Breakthrough Designation for ResistancePlus® GC
New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment
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KIT CHECK: Brings Next-Generation Medication Tracking Mainstream with FDA Pilot
Pilot looks to implement tech that improves the tracking of powerful drugs and interoperability of software throughout the supply chain
ORION BIOTECHNOLOGY: Announces Receipt of Pre-IND Guidance From the United States FDA on the Further Development of OB-002O as a Potential Treatment for Solid Tumors
Orion Biotechnology Canada Ltd., announced that it has received feedback from the Food and Drug Administration (FDA) on a Pre-Investigational New Drug (PIND) application which was submitted in March 2019.