As part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
Agency Continues to Support Competition in Generic Drugs, Increasing Patient Access to More Affordable Medicines
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First combination of ibuprofen and acetaminophen for pain relief to be available OTC in 2020
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)
First and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT)
A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list.
First Ever FDA Approved Potassium Phosphates Injection Expected to Address Previous Market Shortages and Provide Improved Safety Profile as Opposed to Using Unapproved 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.
Transition is Expected to Increase Patient Access and Potentially Lower Prices on Insulin
First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail
Expand TAZVERIK™ Label into Second Indication
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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.
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.
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.
FDA Grants Priority Review and sets PDUFA Date of August 13, 2020
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."
Ethos represents a new chapter in democratized cancer care
Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting
RRP is a rare, potentially fatal orphan disease caused by Human Papillomavirus (HPV) 6 and 11
KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients