Sunday, April 28, 2024

Sunday, April 28, 2024

Latest News

MEDICINE360: FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest Approved Duration of Use of Any Hormonal IUDs

FDA Approval

By Press release submission | Oct 28, 2019

Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.

ALLERGAN PLC: FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

FDA Approval

By Press release submission | Oct 25, 2019

Approval Marks 11th BOTOX® Therapeutic Indication and Comes 30 Years After the First Indications Were Approved

BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

Regulation

By Press release submission | Oct 24, 2019

BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

WOLFE EYE CLINIC: U.S. Food & Drug Administration Approves New Wet Age-Related Macular Degeneration Treatment

FDA Approval

By Press release submission | Oct 24, 2019

The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic

ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA

Regulation

By Press release submission | Oct 23, 2019

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

NOVO NORDISK: FDA approves Fiasp® for use in insulin infusion pumps for adults with type 1 or type 2 diabetes

FDA Approval

By Press release submission | Oct 23, 2019

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes.1 Fiasp®, a rapid-acting insulin, was approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injection (MDI) in adults with diabetes.

BERGENBIO ASA: Receives FDA Approval of Fast Track Designation for Bemcentinib

Reform

By Press release submission | Oct 22, 2019

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.

U.S. FDA: Approves new breakthrough therapy for cystic fibrosis

FDA Approval

By Press release submission | Oct 22, 2019

Treatment approved for approximately 90% of patients with cystic fibrosis, many of whom had no approved therapeutic options

SOPHIRIS BIO: Receives Positive Feedback from FDA Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design

Patients

By Press release submission | Oct 21, 2019

Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer.

JANSSEN: Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

FDA Approval

By Press release submission | Oct 21, 2019

In the Phase 3 pivotal trial, more than 40 percent of patients receiving STELARA subcutaneous (SC) injections every 8 weeks were in clinical remission at one year and not taking corticosteroids

NEUREN: FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes

Patients

By Press release submission | Oct 20, 2019

Neuren Pharmaceuticals (ASX: NEU) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Neuren’s NNZ-2591 for the treatment of Angelman syndrome, Phelan-McDermid syndrome and Pitt Hopkins syndrome.

GENENTECH: Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

FDA Approval

By Press release submission | Oct 20, 2019

Single-dose Xofluza is the first and only antiviral medicine indicated specifically for patients at high risk of developing serious complications from influenza (flu)

DAIICHI SANKYO: [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Patients

By Press release submission | Oct 19, 2019

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review.

AMERICAN GENE TECHNOLOGIES: IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies

Reform

By Press release submission | Oct 19, 2019

Progress Toward the Goal of Achieving a Functional Cure for HIV Disease

JANSSEN: Presents New Four-Year TREMFYA® (guselkumab) Data Demonstrating Maintained Rates of Skin Clearance in Adult Patients with Moderate to Severe Plaque Psoriasis

Patients

By Press release submission | Oct 18, 2019

At 204 weeks, patients receiving TREMFYA® in a clinical study continue to show maintained PASI 90 and IGA 0/1 responses

AMGEN: Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia

FDA Approval

By Press release submission | Oct 18, 2019

32% of Patients Achieved Treatment-Free Remission for at Least Six Months in a Single-Arm Trial

AMERICAN ASSOCIATION OF ORTHODONTISTS: California Passes Dental Law Regarding Self-Applied Orthodontic Treatments

Regulation

By Press release submission | Oct 17, 2019

On October 13, 2019, California Governor Gavin Newsom signed Assembly Bill 1519 into law, granting the California Dental Board continued authority to oversee and regulate dental services in the state.

FOAMIX: Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea

Drug Shortages

By Press release submission | Oct 17, 2019

PDUFA Target Action Date of June 2nd, 2020

OMEGA MEDICAL IMAGING: First in the World to Receive FDA Clearance on Artificial Intelligence Imaging System That Reduces Dose

FDA Approval

By Press release submission | Oct 16, 2019

Omega Medical Imaging, manufacturers of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, just announced the Food and Drug Administration 510 (k) clearance of FluoroShield™ with their 2020 Cardiac Flat Panel Detector.

DENOVO BIOPHARMA: Receives FDA's Permission to Proceed with a Biomarker-Guided Phase 2b Clinical Trial with DB102 (Enzastaurin) In First-Line Treatment of Glioblastoma (GBM)

Patients

By Press release submission | Oct 15, 2019

pies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination with radiation an

FDA Health News