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ABBVIE: Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women

By Press release submission | Aug 5, 2019

MCKESSON: NUBEQA® (darolutamide), FDA Approved for Treatment of High-Risk Non-Metastatic Prostate Cancer, Available at Biologics by McKesson

By Press release submission | Aug 1, 2019

AGILENT TECHNOLOGIES INC.: Agilent Companion Diagnostic Gains Expanded FDA Approval in Esophageal Squamous Cell Carcinoma (ESCC)

By Press release submission | Jul 31, 2019

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US MEDICAL INNOVATIONS: USMI and JCRI-ABTS Receive FDA Approval to Conduct the First U.S. Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Cancer

By Press release submission | Jul 31, 2019

US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS)™, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the first clinical trial in the U.S. to evaluate Cold Atmospheric Plasma (CAP) Technology for the treatment of cancer.

RON SIMON & ASSOCIATES: First Mexican Basil Cyclospora Lawsuit Filed by National Food Safety Law Firm of Ron Simon & Associates as FDA Identifies 132 Victims in Mexican Basil Cyclospora Outbreak

By Press release submission | Jul 29, 2019

The national food safety law firm of Ron Simon & Associates filed the first lawsuit against Siga Logistics de RL de CV, the Mexican producer and importer of fresh basil linked by health officials to a nationwide cyclospora outbreak.

TRC HEALTHCARE: New Tool Helps Healthcare Providers Leverage FDA's Dietary Supplement Ingredient Advisory List To Inform Care Decisions And Advise Patients

By Press release submission | Jul 26, 2019

The Natural Medicines FDA Advisory tool identifies commercial products containing ingredients flagged by the FDA, and provides resources on safety and use to help mitigate risks to patients.

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

By Press release submission | Jul 25, 2019

The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.

APIC BIO: Apic Bio’s APB-102 Receives Orphan Drug Designation from the FDA for the Treatment of Genetic SOD1 ALS

By Press release submission | Jul 22, 2019

Apic Bio, Inc., an innovative gene therapy company developing novel treatment options for patients with rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).

SUN PHARMA: Introduces Access Program for Patients Prescribed XELPROS in the U.S.

By Press release submission | Jul 19, 2019

Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceuticals Inc, USA, which is a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Ltd. (Sun Pharma), has launched XELPROS Xpress™ - an access program for patients prescribed XELPROS™ (latanoprost ophthalmic emulsion) 0.005%.

PEAR THERAPEUTICS: Announces FDA Submission for Somryst™, a Prescription Digital Therapeutic for the Treatment of Adults with Chronic Insomnia and Depression

By Press release submission | Jul 18, 2019

The pending submission is supported by data from two randomized controlled clinical trials of more than 1,400 patients

ALLERGAN PLC: U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension

By Press release submission | Jul 18, 2019

Allergan continues advancement in eye care innovation, developing specialized treatments for patients

ASTELLAS PHARMA INC.: Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

By Press release submission | Jul 16, 2019

Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology

DISCGENICS, INC.: First Utahns treated in nationwide FDA-allowed clinical study of locally developed cell therapy for chronic low back pain

By Press release submission | Jul 12, 2019

DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).

SYNDAX PHARMACEUTICALS: Announces FDA Clearance of IND Application for Targeted Menin Inhibitor SNDX-5613 for Relapsed/Refractory Acute Leukemias

By Press release submission | Jul 11, 2019

SNDX-5613 is a potent, highly selective, oral inhibitor of the interaction of Menin with the Mixed Lineage Leukemia (MLL) protein

OMEROS CORPORATION: Announces Agreement with FDA on Primary Endpoint for Narsoplimab BLA in Stem Cell Transplant-Associated TMA

By Press release submission | Jul 11, 2019

All Criteria for the Response-Based Endpoint Now Finalized

MERCK: FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications

By Press release submission | Jul 9, 2019

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option.

KARYOPHARM THERAPEUTICS: Karyopharm Announces FDA Approval of XPOVIO™ (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

By Press release submission | Jul 4, 2019

XPOVIO is the First and Only Nuclear Export Inhibitor Approved by the FDA

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

By Press release submission | Jul 2, 2019

The U.S. Food and Drug Administration is providing an update on its investigation into reports of dilated cardiomyopathy (DCM) in dogs eating certain types of pet food.

U.S. FOOD AND DRUG ADMINISTRATION: FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

By Press release submission | Jun 24, 2019

The U.S. Food and Drug Administration expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.

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

By Press release submission | Jun 22, 2019

Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range

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