SIMULATIONS PLUS: Enters into New Research Collaboration Agreement with the FDA
Center for Veterinary Medicine to apply GastroPlus® to assess product bioequivalence in canines
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Promising cancer treatment awaits approval
New cancer treatments known as chimeric antigen receptor (CAR) T cell therapy are awaiting approval from the Centers for Medicare and Medicated Services (CMS) to be financially covered for outpatients in cancer centers or clinics.
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NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone
MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals' product Zytiga©, on July 9th.
HALOZYME THERAPEUTICS, INC.: Halozyme Announces Janssen Submits BLA To FDA For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.
JOHNSON & JOHNSON: Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation
Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO
NEOVASC, INC.: Neovasc to Explore HDE Approval Pathway and Alternate Trial Designs for the Reducer Following Guidance from the FDA
Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that the Food and Drug Administration ("FDA") has provided guidance to the Company following its Sprint Discussion on June 26, 2019, together with the Company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer™ (the "Reducer"), to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need.
Former FDA head Scott Gottlieb appointed to Pfizer’s board of directors
Former Food and Drug Administration Commissioner Scott Gottlieb joined pharmaceutical corporation Pfizer’s board of directors on June 27, after stepping down from the FDA in April.
TSG CONSULTING: Urges Medical Device Manufacturers to Take Advantage of FDA's Pre-sub Meeting Program
With the majority of 510(k) submissions having major deficiencies or being rejected the first time, scientific and regulatory experts TSG Consulting recommend that manufacturers schedule a Pre-Submission (Pre-Sub) meeting with the FDA to improve the likelihood of the medical device being approved for sale in the US market.
NATIONAL INDUSTRIAL HEMP COUNCIL: Food and Drug Administration (FDA) to Speak at National Industrial Hemp Council (NIHC) 2019 Hemp Business Summit
The NIHC is pleased to announce Lowell Schiller as a keynote speaker at the National Industrial Hemp Council's 2019 Business Summit.
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MOLECULIN BIOTECH, INC.: Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation
Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has filed new patents covering the production and reconstitution of Annamycin, which is currently in two clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML).
24 medical devices OK’d by FDA so far this year
Twenty-four medical devices have been approved as of June 18 for prescribed uses, according to the federal Food and Drug Administration.
RESEARCH AND MARKETS: Venclexta (venetoclax; AbbVie/Roche) Drug Overview & Product Profile 2017-2026: A Novel B-Cell Lymphoma 2 (BCL-2) Inhibitor that Received an Accelerated US FDA Approval
The "Venclexta" report has been added to ResearchAndMarkets.com
KOIOS MEDICAL: FDA Clears Koios DS™ Breast 2.0 to Assist Physicians with AI-Based Software
Koios Medical, Inc has received 510(k) clearance from the U.S. Food and Drug Administration for Koios DS (Decision Support) Breast 2.0, a new version of its machine learning based platform that assists physicians in the classification and diagnosis of breast cancer.
ANATOMAGE: Releases Anatomage Cloud Platform Featuring One-Click Review to Provide HIPAA Compliant, FDA Approved Free DICOM Sharing and Medical Image Viewing
Anatomage Inc., a market leader in 3D medical imaging technology, released an update to the Anatomage Cloud platform that allows medical and dental professionals to quickly send 3D DICOM volumetric data to colleagues for one-click review.
ICOTEC MEDICAL: icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System
icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures.
Doctor says FDA should do more to combat opioid crisis
The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.
Drug companies want clarity on FDA guidelines for bispecific antibodies
A group of major pharmaceutical companies is asking the US Food and Drug Administration to consider changes to the agency's guidelines on developing bispecific antibodies.
Flaws in the system allow Clinicaltrials.gov to host illegal trails
The website Clinicaltrials.gov is home to a broad spectrum of clinical trials, both legitimate and illegal, according to FDAMap.com.
U.S. FOOD AND DRUG ADMINISTRATION: Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems
Mortality linked to paclitaxel-coated devices remains unresolved
A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).