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Federal health officials are warning sunscreen companies for violating drug regulations by selling products in unapproved ...
The alert follows a wave of warning letters the agency sent to Supergoop!, Vacation Inc. and three other popular brands, accusing them of peddling whipped, mousse and foam sunscreens that flout ...
An update from Shanghai Henlius Biotech, Inc. Class H ( ($HK:2696) ) is now available. Shanghai Henlius Biotech, Inc. announced that its New Drug ...
The FDA approved an investigational new drug application for ABT-301, clearing the way for a new clinical trial in metastatic ...
With a supplemental new drug application, a pharmaceutical company seeks to make changes to drug labels after they have been approved for other indications, for example, according to the FDA’s website ...
Glaukos submitted a new drug application to the FDA for Epioxa, an epithelium-on corneal cross-linking iLink therapy for the treatment of keratoconus, according to a company press release.
U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.
A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in a phase 2 clinical trial for individuals with ...
The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint ...
The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many ...
2don MSN
Healthy Returns: FDA launches program to streamline creation of new U.S. drug manufacturing sites
A new FDA program will use a two-phase approach to help boost domestic drug manufacturing, while OpenAI is leaning into health care with the launch of GPT-5.
The application is supported by data from 2 randomized, open-label, multicenter phase 3 clinical studies (NCT04292730 and NCT04292899) conducted by Gilead and a randomized, placebo-controlled ...
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