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At the U.S. Food and Drug Administration we continue to closely monitor the supply chain effects of closures and potential closures of specific large-scale sterilization facilities that use a gas called ethylene oxide to sterilize certain medical devices prior to their use.
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Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods
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The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
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Clinic had significant donor eligibility violations, including donor screening and testing
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution.
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Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced that the new drug application ("NDA") submitted by Incyte to the U.S. Food and Drug Administration ("FDA") for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.
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Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections.
New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement
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The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI® (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.
Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019
Potential for UGN 101 to be First Non-Surgical Therapy for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
Forward Science received FDA Clearance for OrapeuticTM, a non-opioid oral pain relief gel. Forward Science is a MedTech company that operates R&D, its quality system, manufacturing, sales and support all from its Worldwide headquarters in Houston, TX.
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD), which was resubmitted on November 21, 2019. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 21, 2020.
First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
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Action Represents Another Milestone for the Global Partnership Against Ebola
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ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.