Stories | FDA Health News

Home
»
Stories
»
FDA Approval

FDA Approval

REDHILL BIOPHARMA: Announces FDA Acceptance of New Drug Application for Talicia®

By Press release submission | Jul 5, 2019

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for refractory multiple myeloma

By Press release submission | Jul 4, 2019

PERRIGO COMPANY PLC: Perrigo Announces FDA Final Approval and Launch Of The AB-rated Generic Version Of Metrogel-Vaginal® Gel

By Press release submission | Jul 3, 2019

Latest News

PUMA BIOTECHNOLOGY: Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

By Press release submission | Jul 3, 2019

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

By Press release submission | Jul 1, 2019

The U.S. Food and Drug Administration approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.

New non-insulin treatment for type 2 diabetes approved

By John Severance | Jun 27, 2019

The Food and Drug Administration recently approved the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.

JOHNSON & JOHNSON: Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible

By Press release submission | Jun 27, 2019

Combination regimen reduced the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

By Press release submission | Jun 24, 2019

The U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

ALEXION: U.S. FDA Accepts Supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz) under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)

By Press release submission | Jun 22, 2019

FDA sets target action date of October 19, 2019

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

By Press release submission | Jun 21, 2019

DEXTENZA Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery

ALLERGAN, PLC: FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

By Press release submission | Jun 21, 2019

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.

Questions raised over cancer drugs in FDA's accelerated approval program

By John Severance | Jun 19, 2019

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.

MERCK: FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

By Press release submission | Jun 19, 2019

Marks First Approval for KEYTRUDA in SCLC

TORQUE: FDA Grants Fast Track Designation for Torque's First Deep-Primed T Cell Cancer Immunotherapy Program, TRQ-1501

By Press release submission | Jun 18, 2019

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).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for pediatric patients with type 2 diabetes

By Press release submission | Jun 17, 2019

The U.S. Food and Drug Administration approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes.

MERCK: FDA Approves Two New Indications for Merck’s KEYTRUDA® (pembrolizumab)

By Press release submission | Jun 14, 2019

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

By Press release submission | Jun 14, 2019

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

Device may offer relief to teens with irritable bowel syndrome

By Keri Carbaugh | Jun 13, 2019

The IB-Stim would be used in combination with other IBS therapies.

CERTARA: Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

By Press release submission | Jun 13, 2019

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

By Press release submission | Jun 12, 2019

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).

FDA Health News