.jpg){kind=tracking}
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
Latest News
Device may offer relief to teens with irritable bowel syndrome
The IB-Stim would be used in combination with other IBS therapies.
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.
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.
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
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
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.
.jpg){kind=tracking}
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.
.jpg){kind=tracking}
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).
.jpg){kind=tracking}
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.
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.
.jpg){kind=tracking}
CAMURUS AB: Camurus Receives IND Acceptance From the FDA to Enter Phase 3 with CAM2029 for Treatment of Acromegaly
Camurus (NASDAQ STO: CAMX), a commercial stage biopharmaceutical company specializing in long-acting medicines for severe and chronic disorders, announced today the acceptance by the US Food and Drug Administration (FDA) of an Investigational New Drug (IND) application to initiate a Phase 3 study with CAM2029 once-monthly octreotide subcutaneous depot for treatment of acromegaly.
46 food, dietary supplement recalls initiated
Food producers carried out 46 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
FDA improving its regulation of cannabis products: Kline
The FDA is working toward better regulation of cannabis-based products, consulting services firm Kline said after a public hearing with the U.S. regulatory body.
Doctor says concern over ‘forever’ chemicals a matter of chemophobia
Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness, believes it’s the latest example of chemophobia.
.jpg){kind=tracking}
ALLERGAN, PLC: FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care.
.jpg){kind=tracking}
OCULAR THERAPEUTIX: Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA (0.4 Dexamethasone Intracanalicular Insert for Ophthalmic Use) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
DEXTENZA Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
.jpg){kind=tracking}
VERTEX: FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range