Tag: FDA

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

US Senate Committee Advanced Nomination of Stephen Hahn to Lead FDA

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A Senate committee advanced the nomination of Dr. Stephen Hahn, a noted oncologist and cancer researcher, to lead the Food and Drug Administration. Dr. Hahn, a chief medical executive at th...

FDA Granted Orencia Breakthrough Therapy Status

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host dise...

FDA Finalized Guidance on Adaptive Clinical Trial Designs for Drugs and Biologics

clinical-trial-material
The US Food and Drug Administration (FDA) last week finalized guidance on adaptive clinical trial designs for drugs and biologics. The 33-page guidance, which finalizes a draft version released for...

FDA Accepted sBLA and Granted Priority Review for Imfinzi

astrazeneca
AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treat...

FDA Warned EPH Technologies for Taking Orders for Various Unapproved New Drugs

The US Food and Drug Administration (FDA) sent a warning letter to New Mexico-based EPH Technologies for taking orders on its website for various unapproved new drugs. The unapproved drugs are mean...

Verrica Pharma NDA for VP-102 Accepted by FDA

Verrica Pharmaceuticals Inc., a medical dermatology company, announced that its New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatme...

FDA Approved Biocon New Facility at Bengaluru

biocon
The US Food and Drug Administration (FDA) has approved Biocon Ltd's new facility at Bengaluru for the manufacturing of pegfilgrastim biosimilar Fulphila, the company said in a release. Approval for...

Hikma Submitted Response for Advair® to FDA

hikma
Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, announces that it has submitted to the US Food and Drug Administration (FDA) its response to deficiencies in its abbreviate...

FDA Accepted Incyte’s NDA for Priority Review of Pemigatinib

The US Food and Drug Administration (FDA) has accepted Incyte’s new drug application (NDA) for the priority review of its pemigatinib to treat patients with cholangiocarcinoma. The NDA has been...

Evofem Biosciences Resubmitted Application to FDA for Amphora®

Evofem Biosciences, Inc., a clinical-stage biopharmaceutical company, announced that it has resubmitted New Drug Application to the U.S. Food and Drug Administration (FDA) for Amphora®, a Multipurpose...

New Costly Drugs Approved by FDA Before PDUFA Dates

fda
Since 21 October, the US Food and Drug Administration (FDA) has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected...

FDA Issued Warning Letters to 15 Companies for Illegally Selling Products Containing Cannabidiol

The U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (...

FDA Granted Priority Review for Risdiplam for SMA Treatment

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for risdiplam, an investigati...

Precision Dose Recalls Five Lots of Ranitidine Oral Solution in the US

The US Food and Drug Administration (FDA) has announced that Precision Dose Inc, is issuing a voluntary nationwide recall of ranitidine oral solution. The five lots involved in the recall are...

FDA Granted Rare Pediatric Disease Designation for Sarizotan

Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announced that the U.S...

FDA Granted Qualified Infectious Disease Product and Fast Track Designation for ATM-AVI

allergan
Allergan plc announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam),...