LA ROCHE-POSAY: Changes The Face Of Acne With Latest FDA Approved Acne Ingredient And Premieres Artificial Intelligence-Based Skin Analysis
La Roche-Posay Launches Effaclar Adapalene Gel 0.1% Acne Treatment and My Skin Track PoreScan
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DISCGENICS, INC.: First Utahns treated in nationwide FDA-allowed clinical study of locally developed cell therapy for chronic low back pain
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
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
All Criteria for the Response-Based Endpoint Now Finalized
FDA Update: June 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.
AZURITY PHARMACEUTICALS: FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older
Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.
CONTIPI MEDICAL LTD: Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women
This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder).
MERCK: FDA Accepts Merck’s Supplemental Biologics License Applications for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule for Melanoma and Multiple Other Indications
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.
Electronic skin patch companies grapple with changing reimbursement schemes, report says
Ever-changing reimbursement schemes are forcing firms involved in electronic skin patches to lobby and adapt or leave the sector altogether, a research report surveying the product category said.
Daiichi Sankyo issues update on new cancer drug
Japanese pharmaceutical company Daiichi Sankyo recently announced it received a complete response letter (CRL) from the Food and Drug Administration (FDA) for the New Drug Application (NDA) of the cancer-fighting drug quizartinib.
FDA panel: more research needed on potentially negative effects associated with paclitaxel-coated device treatment
While the long-term effects of treatment with paclitaxel-coated devices in the peripherals are still unclear, the U.S. Food and Drug Administration could not rule out an association with adverse effects, even at very low drug concentrations.
BIOTRONIK: Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III
Device is 60% Smaller, Offers Simplified One-Step Injection Procedure and Sets New Standard for Signal Quality
Cybersecurity issues lead to recall of some Medtronic insulin pumps
Medtronic MiniMed 508 and MiniMed Paradigm series insulin pumps are being recalled because of cybersecurity concerns, according to the Food and Drug Administration.
INSYS THERAPEUTICS, INC: FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose
INSYS Therapeutics, Inc. (OTCMKTS: INSYQ), announced that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing.
REDHILL BIOPHARMA: Announces FDA Acceptance of New Drug Application for Talicia®
U.S. FDA accepts NDA for priority review
6 drugs recalled during June, FDA reports
Six drugs were recalled in June to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
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KARYOPHARM THERAPEUTICS: Karyopharm Announces FDA Approval of XPOVIO™ (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
XPOVIO is the First and Only Nuclear Export Inhibitor Approved by the FDA
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for refractory multiple myeloma
The U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
PERRIGO COMPANY PLC: Perrigo Announces FDA Final Approval and Launch Of The AB-rated Generic Version Of Metrogel-Vaginal® Gel
Perrigo Company plc (NYSE; TASE: PRGO) announced its product development partner received final approval from the U.S. Food and Drug Administration for its AB-rated Abbreviated New Drug Application ("ANDA") referencing Metrogel-Vaginal® (metronidazole vaginal gel 0.75%).
PUMA BIOTECHNOLOGY: Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
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).