FDAgpt Archives - Page 31 of 35

July 11, 2023 Artificial Intelligence FDAcop

FDA Updates: July 11, 2023

The U.S. Food and Drug Administration (FDA) has provided an update on various activities happening within the agency. One of the main focuses is the prevention of illicit xylazine from entering the United States. The FDA’s Center for Veterinary Medicine (CVM) is working in collaboration with other FDA offices and the Department of Health and […]

July 11, 2023 Artificial Intelligence FDAcop

Septerna Secures $150M Financing Led by RA Capital for Groundbreaking Oral Edge Drug in Rare Hormone Disease

Septerna Therapeutics has secured $150 million in Series B financing to support the development of its small molecule drug candidate for the treatment of hypoparathyroidism. The funding round was led by RA Capital Management and included participation from a range of investors, including Deep Track Capital, Goldman Sachs Asset Management, and Vertex Ventures HC, among […]

July 10, 2023 Artificial Intelligence FDAcop

FourPlus, an immersive tech company, secures funding to develop a cutting-edge mixed reality platform.

UK-based immersive technology company FourPlus has secured funding from Innovate UK, the UK’s national innovation agency, to develop a mixed reality training platform for pharmaceutical companies and the healthcare sector. FourPlus already uses its immersive technology, including virtual reality experiences, in the life sciences sector for marketing, training, and workforce management. With a ₤1 million […]

July 10, 2023 Artificial Intelligence FDAcop

First Cell Therapy for Type 1 Diabetes Receives FDA Approval, Made Possible by Startup’s Success

CellTrans, a small biotech company, has received the first FDA approval for a cell therapy for type 1 diabetes. The therapy, known as Lantidra, is intended for adults with type 1 diabetes who are unable to achieve their target blood glucose levels through regular insulin administration. Lantidra, which is made from pancreatic cells sourced from […]

July 10, 2023 Artificial Intelligence FDAcop

Toxicity Concerns Cast Uncertainty on Phase 3 Results of AstraZeneca and Daiichi Cancer Drug

A targeted cancer therapy developed by AstraZeneca and Daiichi Sankyo has shown promising results in a Phase 3 study for advanced non-small cell lung cancer (NSCLC). The drug, called datopotamab deruxtecan, demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy. However, the companies also disclosed that an unspecified number of patient deaths occurred […]

July 10, 2023 Artificial Intelligence FDAcop

Johnson & Johnson to Conduct Phase 3 Trial to Stay Competitive in the Pursuit of Oral Psoriasis Medications

Johnson & Johnson (J&J) is making progress in developing a pill formulation to treat plaque psoriasis, a skin disorder that is currently treated with injectable biologic drugs. The company presented mid-stage data for its experimental drug JNJ-2113 at the World Congress of Dermatology meeting in Singapore. The study showed that a higher proportion of patients […]

July 10, 2023 Artificial Intelligence FDAcop

FDA Removes Partial Hold on Curis Drug, Enabling Progression to Phase 2 Leukemia Study

Lexington, Massachusetts-based biotech company Curis has received clearance from the FDA to resume a clinical trial that was placed on hold for over a year. The trial is testing the drug emavusertib, which is designed to block the enzyme IRAK4, involved in certain cancers and inflammatory diseases. The trial was put on hold after a […]

July 9, 2023 Artificial Intelligence FDAcop

Update from the FDA: June 6, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates. First, the FDA issued a letter to health care providers recommending conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs. The agency provided a list of best practices for cleaning and sterilization/disinfection of these devices and recommended the use of […]

July 9, 2023 Artificial Intelligence FDAcop

Gratitude Expressed | Analysis of Life Sciences

The FDA’s Office of Pharmaceutical Quality (OPQ) recently published a report on the current state of pharmaceutical quality. However, there are some concerns and gaps in the report’s information. The creation of OPQ was aimed at addressing the lack of quality-related information available outside of the product review process and post-approval inspections. The office aims […]

July 9, 2023 Artificial Intelligence FDAcop

FDA News Roundup: June 9th, 2023

In a recent announcement, the U.S. Food and Drug Administration (FDA) provided updates on various topics related to healthcare and medical devices. Here are the key highlights: Oxygenator Device Recall: The FDA issued a letter to healthcare providers and facilities regarding a recall notice by Getinge/Maquet for Quadrox Oxygenators. The letter includes recommendations for healthcare […]

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