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Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava

Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava

Outlook Therapeutics Secures FDA Approval for AMD Drug Lytenava
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FDA Advisory Committee Recommends Loosening Restrictions on Popular Peptides Amid Safety Concerns

FDA Advisory Committee Recommends Loosening Restrictions on Popular Peptides Amid Safety Concerns

A U.S. Food and Drug Administration (FDA) advisory committee has recommended easing restrictions on certain popular peptides, which are marketed for benefits such as anti-aging and muscle recovery. These peptides, often available through a regulatory gray market, have been identified by the FDA as posing significant safety risks due to limited human research supporting their safety and effectiveness. The committee's vote has sparked controversy in medical circles, as many of these peptides lack adequate human clinical evidence for their marketed uses. The peptides under review include Body Protection Compound-157, KPV, TB-500, MOTS-c, Semax, and Epitalon, which are promoted for various health benefits but have limited supporting evidence from human trials.
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Peptides Gain Popularity in Wellness Industry Amid Regulatory Concerns

Peptides Gain Popularity in Wellness Industry Amid Regulatory Concerns

Peptides Gain Popularity in Wellness Industry Amid Regulatory Concerns
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Recall Issued for AMS Aligned Medical Solutions Kits Due to Lidocaine Contamination

Recall Issued for AMS Aligned Medical Solutions Kits Due to Lidocaine Contamination

Windstone Medical Packaging has initiated a recall of specific Aligned Medical Solutions (AMS) convenience kits due to contamination issues with Elevaris Lidocaine HCl injection USP. The recall affects various medical kits, including Loop Recorder Packs and Biopsy Trays, distributed across the United States. The contamination was identified as a supplier quality issue, prompting the recall to prevent potential risks to patients. The recall notice advises healthcare facilities to quarantine affected products and follow specific procedures to ensure the contaminated Lidocaine is not used.
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FDA Advisory Committee Recommends Lifting Regulations on Experimental Peptides Amidst Safety Concerns

FDA Advisory Committee Recommends Lifting Regulations on Experimental Peptides Amidst Safety Concerns

A U.S. drug advisory committee has recommended that the FDA lift regulations on several experimental peptides, allowing select pharmacies to manufacture and doctors to prescribe them. This decision comes despite the lack of large-scale human trials to support the safety and efficacy of these compounds. Peptides, which are short chains of amino acids, are being marketed for a variety of health benefits, including anti-aging and injury healing. The unregulated market for these peptides is estimated to be worth between $100 million and $3 billion. The committee's recommendation aims to mitigate risks associated with purchasing these products from unregulated sources, but it also raises concerns about the message it sends regarding their safety.
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Nutrition Experts Advise on Dietary Choices for GLP-1 Users with Type 2 Diabetes

Nutrition Experts Advise on Dietary Choices for GLP-1 Users with Type 2 Diabetes

A recent study highlights the importance of specific dietary choices for individuals taking GLP-1 medications for type 2 diabetes. These medications, which are used to manage blood sugar levels, can suppress appetite, making it challenging for patients to consume adequate nutrients. Experts recommend focusing on nutrient-dense, low-calorie foods, including lean proteins, low-fat dairy, and fiber-rich fruits and vegetables. Dr. Jennifer Nasser, an associate professor of nutrition sciences, emphasizes the need for patients to monitor their dietary intake to prevent muscle mass loss and manage blood sugar spikes. The study suggests that prioritizing protein and fiber can help maintain muscle mass and reduce post-meal blood sugar spikes, which are crucial for managing diabetes effectively.
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MapLight's Schizophrenia Drug Faces Challenges After Mixed Phase 2 Trial Results

MapLight's Schizophrenia Drug Faces Challenges After Mixed Phase 2 Trial Results

MapLight's Schizophrenia Drug Faces Challenges After Mixed Phase 2 Trial Results
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FDA Announces Educational Webinar on Expedited IND Pilot Program

FDA Announces Educational Webinar on Expedited IND Pilot Program

The U.S. Food and Drug Administration (FDA) has announced an educational webinar scheduled for August 6, 2026, to discuss the proposed Expedited Investigational New Drug (IND) pilot program. This initiative aims to accelerate the transition from drug identification to first-in-human clinical trials. The program will establish a network of Qualified Research Institutions (QRIs), including academic medical centers, healthcare networks, and contract research organizations, to partner with sponsors in developing and reviewing protocols for IND submissions. The webinar will provide stakeholders with detailed information about the program's objectives and solicit feedback.
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FDA Advisers Vote on Peptides for Drug Compounding List, Await Final Decision

FDA Advisers Vote on Peptides for Drug Compounding List, Await Final Decision

FDA advisers have narrowly voted to add six peptides to a drug compounding list, a decision that is non-binding and requires final approval from the FDA. This vote is part of ongoing efforts to regulate and expand the list of substances that can be legally compounded by pharmacies. The decision comes amid growing interest in the use of peptides for various therapeutic purposes, including their potential benefits in treating chronic conditions. The FDA's final decision will determine whether these peptides can be compounded, impacting pharmacies and patients seeking alternative treatment options.
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CMS Proposes New Guidance for Medicare Drug Price Negotiation Program

CMS Proposes New Guidance for Medicare Drug Price Negotiation Program

The Centers for Medicare & Medicaid Services (CMS) has released draft guidance for the implementation of the Maximum Fair Price (MFP) in 2028 under the Medicare Drug Price Negotiation Program. This guidance, published on July 16, 2026, is part of the ongoing efforts to manage drug pricing under the Inflation Reduction Act. CMS is seeking public comments on this draft, with a deadline set for September 18, 2026. The proposed rule also includes changes to the Part D inflation rebate program, such as defining the 'first marketed date' for drugs. Additionally, the 2027 Physician Fee Schedule proposed rule requires 340B covered entities to submit Part D claims data, aiming to improve the accuracy of rebate calculations.
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Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication

Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication

Food Network's Katie Lee Discusses Positive Experience with GLP-1 Medication
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Goldman Sachs sees writing on the wall for Eli Lilly stock

Goldman Sachs sees writing on the wall for Eli Lilly stock

Eli Lilly (LLY) stock has turned into one of the best comeback trades of 2026. Shares closed at $1,196.03 on July 24, up nearly 11% year to date after a rough start dragged the stock below $900 in the spring. Lilly shares have climbed about 39% since the company's first-quarter report, according to ...