Drug User Articles & Analysis
21 news found
Oral Thin Film Technology is a user-friendly drug delivery method involving the placement of a thin film strip in the oral cavity, where it quickly dissolves and releases medication directly into the bloodstream. ...
CARLSBAD, Calif., March 7, 2023 /PRNewswire/ -- Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy ...
(“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight. ...
People with light sensitivity and recent users of light-sensitive drugs, whose skin is sensitive to light, are prone to skin damage after treatment. 5. ...
” In March 2022, the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic CCA harboringFGFR2 gene rearrangements, including gene fusions. The FDA provided an anticipated Prescription Drug ...
PRINCETON, N.J., MARCH 30, 2022 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboringFGFR2 ...
November 2020?by the?U.S. Food and Drug Administration?(FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and in July ...
Berkshire Biomedical Corporation (“Berkshire” or “the Company”), focused on developing drug delivery devices designed to accurately and precisely deliver oral liquid drugs only to the biometrically authenticated Intended User, provide remote monitoring and enhance patient wellness, announced today that John Timberlake, ...
Novartis announced today that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castrationresistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post ...
Berkshire Biomedical, LLC (“Berkshire” or “the Company”), focused on developing drug delivery devices designed to precisely deliver oral liquid drugs only to the biometrically authenticated Intended User, provide remote monitoring and enhance patient wellness, announces today that it joins with the millions of advocates ...
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage ...
Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. ...
To help pharmaceutical companies obtain faster results in their drug discovery process and reduce the cost of bringing new drugs to market, Thermo Fisher Scientific has released the Thermo Scientific iSPA Workflow, the first commercially available single particle analysis (SPA) workflow solution. As pharmaceutical labs turn to cryo-electron microscopy (cryo-EM) ...
On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. ...
Under this contract, Aktiv Pharma Group will advance a pralidoxime chloride (2-PAM) auto-injector toward U.S. Food and Drug Administration (FDA) approval. Subsequently, in 2018, BARDA awarded Aktiv Pharma Group a $15.5 million contract to develop a Good Manufacturing Practice (GMP) manufacturing line for the ARAI autoinjector platform, which was completed in December 2019. 2-PAM ...
ARAI utilizes a glass-free primary drug container, which addresses and corrects the shortfalls found in other autoinjectors. ...
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces that the United States Food and Drug Administration (FDA) has confirmed it has completed its validation for completeness, and accepted for filing and review, the previously submitted Duaklir® New ...
Duaklir® NDA for treatment of chronic obstructive pulmonary disease (COPD) Tudorza® sNDA for inclusion of COPD exacerbation reduction and cardiovascular safety data in label Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New ...
Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. ...
Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. ...