Thursday, April 18, 2024

Thursday, April 18, 2024

Latest News

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.

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

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.

FDA engages software vendor Xybion for data management

FDA Approval

By Bree Gonzales | Oct 22, 2019

The U.S. Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion, a software and consulting firm that will aid in expediting research of new products and medicines.

Physicians committee wants FDA to require breast cancer warnings on cheese products

Regulation

By Adam Hochron | Oct 22, 2019

The Physicians Committee for Responsible Medicine (PCRM) has filed a petition with the U.S. Food and Drug Administration (FDA) that would require a warning label on all dairy cheese products warning about the potential increased risks of developing breast cancer.

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.

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.

FDA approves first topical minocycline for acne treatment

FDA Approval

By Bree Gonzales | Oct 24, 2019

The U.S. Food and Drug Administration (FDA) has approved AMZEEQTM (minocycline) topical foam, 4 percent. Manufactured by Foamix Pharmaceuticals Ltd., AMZEEQ, formerly known as FMX101, is the first topical minocycline to be approved by the FDA for any condition.

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

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.

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

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.

ASTELLAS PHARMA: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury

Patients

By Press release submission | Oct 28, 2019

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.

HERON THERAPEUTICS: Announces FDA Acceptance of New Drug Application Resubmission for HTX-011 for Management of Postoperative Pain

Reform

By Press release submission | Oct 29, 2019

FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of March 26, 2020

IMPLANET: Announces FDA 510(k) Clearance for the MADISON Total Knee Prosthesis

Regulation

By Press release submission | Oct 29, 2019

Global recognition of the MADISON’s clinical value

Mylan recalls anxiety medication Alprazolam

Regulation

By Bree Gonzales | Oct 29, 2019

Mylan Pharmaceuticals Inc. is carrying out a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg, due to the potential presence of a foreign substance.

ALKERMES: Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis

FDA Approval

By Press release submission | Oct 30, 2019

VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability

DisposeRx helps to eradicate millions of opioid pills

Reform

By Bree Gonzales | Oct 30, 2019

Fulfilling its pledge to remove millions of opioid pills from the medicine cabinets of American homes, DisposeRx recently donated over 150,000 packets of its non-toxic, safe solution for the disposal of unused or expired medications to 140 community partners in 43 states through its community outreach program.

FDA plans 24 public meetings in November

Regulation

By FDA Health News Reports | Oct 30, 2019

The U.S. Food and Drug Administration (FDA) has scheduled 24 public meetings, conferences and workshops for November, the agency reported.

IMPULSE DYNAMICS: Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System

FDA Approval

By Press release submission | Oct 30, 2019

Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients

Trending

  1. 1 AMBRX INC.: FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer
FDA Health News