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
Latest News
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)
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GSK CONSUMER HEALTHCARE: FDA approves GSK's Advil Dual Action with Acetaminophen for over-the-counter use in the United States
First combination of ibuprofen and acetaminophen for pain relief to be available OTC in 2020
FDA: Approves First Generic of Daraprim
Agency Continues to Support Competition in Generic Drugs, Increasing Patient Access to More Affordable Medicines
FDA: Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics
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.
FDA: Approves New Therapy for Patients with Previously Treated Multiple Myeloma
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.
FDA: Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel
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.
FDA: Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast
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).
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LUYE PHARMA: NDA Filing for Luye Pharma's Antidepressant Drug LY03005 Accepted by the U.S. FDA
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.
FDA: Approves New Treatment for Adults with Cushing’s Disease
Cushing’s disease is a rare disease in which the adrenal glands make too much of the cortisol hormone.
FDA: Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications
New Draft Guidance Considers Broader Evaluations Beyond Cardiovascular Outcomes Trials
FDA: Approves First Treatment for Group of Progressive Interstitial Lung Diseases
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).
FDA: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher
Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19).
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FDA: Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp
U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
FDA: Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials
The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.