News

FDA, PreCheck and Drug Administration

FDA to start new ‘precheck’ program to boost US drug production
The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many pharmaceutical companies have promised to build.
FDA announces new program to boost domestic drug manufacturing
The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of drug manufacturing facilities in the U.
FDA Moves to Strengthen Drug Supply Chain with PreCheck Program
The agency’s new program is designed to increase regulatory predictability and streamline review of domestic manufacturing facilities.
US FDA moves to boost domestic drug manufacturing after Trump push
The U.S. Food and Drug Administration on Thursday announced a new program to speed up construction and review of drug manufacturing plants in the country to boost domestic drug supply. The program, called FDA PreCheck,
FDA launches program to encourage American drug manufacturing
The U.S. Food and Drug Administration announced Thursday it is launching "FDA PreCheck" in order to help construct drug manufacturing sites in the United States.
FDA moves to boost domestic drug supply
The Food and Drug Administration (FDA) is launching a new program to ramp up the United States’s domestic pharmaceutical supply chain, the agency announced Thursday. The program, called FDA PreCheck,
FDA launches new initiative to boost domestic drug manufacturing
The U.S. Food and Drug Administration (FDA) on Thursday announced FDA PreCheck, a program developed in response to a recent executive order signed by President Donald Trump to encourage domestic drug manufacturing through enhanced regulatory support.
FDA unveils ‘PreCheck’ program for drug manufacturers
As the federal government pushes for lower drug prices and more domestic production, the FDA launched a “PreCheck” program Aug. 7 to expedite approval of new U.S. drug manufacturing facilities.  FDA PreCheck will provide drugmakers more frequent communication with the FDA at “critical development stages,

MAXONA PHARMACEUTICALS SUBMITS INVESTIGATIONAL NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR MAX-001

MAXONA Pharmaceuticals today announced that the company has submitted an Investigational New Drug (IND) Application to the ...
Fierce Pharma12h

Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant buildouts

In line with the Trump administration’s goal to curb the United States’ reliance on overseas drug manufacturing, the FDA has ...
Targeted Oncology17h

FDA Clears Novel Combination Trial for Recurrent Glioblastoma

A new FDA-approved trial explores innovative treatments for recurrent glioblastoma, offering hope for patients facing this ...
CURE3d

FDA Approves Application for ABT-301 in Metastatic Colorectal Cancer

The FDA approved an investigational new drug application for ABT-301, clearing the way for a new clinical trial in metastatic ...
MPR11h

Maintenance of Erosive Esophagitis Healing Observed With Tegoprazan

In the most severe erosive esophagitis patients (LA grade C or D), tegoprazan 100mg was found to be statistically superior to lansoprazole for maintenance of healing at 24 weeks. Noninferiority vs ...

Measles Cases Increasing Worldwide, Need the New NV-387 Broad-Spectrum Antiviral to Combat, Says NanoViricides

SHELTON, CT / ACCESS Newswire / July 30, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the ...
Crain's Chicago Business9d

AbbVie files application for new drug combo to fight leukemia

AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another ...
Healio1d

Topline results: Oral drug combination lowers OSA severity over 51 weeks

Obstructive sleep apnea severity measured via apnea-hypopnea index decreased among patients receiving AD109, an oral ...

Cingulate gets $4.3M waiver, clearing way to submit for FDA approval

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

Lantheus announces FDA review for new radioactive imaging agent

Lantheus Holdings (NASDAQ:LNTH) announced on Wednesday that the U.S. Food and Drug Administration (FDA) accepted its marketing application for a new formulation of its F 18 PSMA radioactive imaging ...