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U.S. FDA: FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic
Critical Milestone Reached in Response to this Outbreak
Latest News
KLEO PHARMACEUTICALS: Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic
KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients
INOVIO: Receives Authorization from the U.S. FDA To Begin Phase 1/2 Clinical Trial for INO-3107, a DNA Medicine To Treat a Rare Disease -- Recurrent Respiratory Papillomatosis (RRP)
RRP is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
JANSSEN ONCOLOGY: Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting
VARIAN: Receives FDA 510(k) Clearance for Ethos Therapy
Ethos represents a new chapter in democratized cancer care
PLASMOLOGY4: FDA Grants Plasmology4® "Breakthrough Device Designation" for the Treatment of Multidrug-Refractory Bacteria
Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company's product has been granted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program for the treatment of "multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed."
DECIPHERA PHARMACEUTICALS: Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors
FDA Grants Priority Review and sets PDUFA Date of August 13, 2020
SEATTLE GENETICS: Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
FDA Action Date is August 20, 2020; Application Under FDA’s Real-Time Oncology Review (RTOR) and Orbis Pilot Programs
MEDICREA: Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages
MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services and technologies, announced today that it has received FDA-Clearance for UNiD® IB3D Patient-Matched interbody cages which completes its UNiD® ASI platform technology.
ASTEX PHARMACEUTICALS: Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.
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U.S. FDA: FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts.
EPIZYME: Announces FDA Acceptance of New Drug Application for Filing with Priority Review for TAZVERIK™ (tazemetostat) for the Treatment of Follicular Lymphoma
Expand TAZVERIK™ Label into Second Indication
FDA: Takes Action with Indian Government to Protect Consumers From Illicit Medical Products
First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail
FDA: Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products
Transition is Expected to Increase Patient Access and Potentially Lower Prices on Insulin
FDA: Approves first generic of ProAir HFA
Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines
FDA: Coronavirus Update: FDA steps to ensure quality of foreign products
We are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak.
CMP PHARMA: First FDA approved Potassium Phosphates Injection from CMP Pharma Has Been Approved
First Ever FDA Approved Potassium Phosphates Injection Expected to Address Previous Market Shortages and Provide Improved Safety Profile as Opposed to Using Unapproved Products
FDA: Coronavirus (COVID-19) Supply Chain Update
A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list.
BIOHAVEN PHARMACEUTICAL: Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults
First and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT)
DEBIOPHARM: FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143 for Front-line Treatment of Head & Neck Cancer
The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination with chemo-radiotherapy presented in September 2019 at the ESMO congress (European Society for Medical Oncology)