The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).
New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials
Cushing’s disease is a rare disease in which the adrenal glands make too much of the cortisol hormone.
.jpg){kind=tracking}
Luye Pharma Group has announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder.
The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency’s most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).
In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings.
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
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
.jpg){kind=tracking}
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.
Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines
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
.jpg){kind=tracking}
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.