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Biotech company Viking Therapeutics Inc saw stock prices double after a report on weight loss drug VK2735. The substantial weight loss from patients on the new medication could put VK2735 alongside groundbreaking products from pharmaceutical giants Eli Lilly and Company and Novo Nordisk A/S (Danish multinational pharmaceutical company).


The Food and Drug Administration (FDA) is investigating the potentially serious side effects of Glucagon-like peptide (GLP-1) receptor agonists, which have become popular weight loss drugs.

GLP-1 decreases both the secretion of acid in the stomach and how quickly food is emptied from the stomach, prolonging the sensation of fullness. This can limit how much a person eats and may ultimately lead to weight loss.


Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, according to results from a phase two clinical trial.


Hollywood celebrities, social media influencers and even billionaire tech mogul Elon Musk have reportedly used popular weight loss drugs like Ozempic and Wegovy to get rid of unwanted weight.


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FDA announced the launch of Cosmetics Direct for electronic Registration and Listing of Cosmetic Facilities and Products on December 18, 2023.


A qualified individual must develop your Foreign Supplier Verification Program (FSVP), and perform each of the required activities. A qualified individual must have the education, training, or experience (or a combination thereof), and must be able to read and understand the language of any records that must be reviewed in performing such activities.


U.S. Food and Drug Administration announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer sold for use in food packaging. This means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers and pet food bags is being eliminated.


Check out the Mobile Health App Interactive Tool, jointly developed by the U.S. FDA and the Federal Trade Commission. The online tool is for anyone developing a mobile app that will access, collect, share, use, or maintain information related to an individual consumer’s health, such as information related to diagnosis, treatment, fitness, wellness, or addiction.


FDA issues warning against the use of over-the-counter supplements that contain an antidepressant called tianeptine, due to serious risks including seizures, loss of consciousness and death.


FDA cleared Alltest Fentanyl Urine Test Cassette, the first over the counter test for the preliminary detection of fentanyl in urine. The test works by placing three drops of fresh urine onto a cassette containing a fentanyl test strip. After 5 minutes the test result will appear as colored lines. The agency expedited review of this test, making a decision in only 16 days from the date the application was received.


Novartis Pharmaceuticals Corporation states through “Long Live” TV ad’s voiceover and on-screen text, that breast cancer drug Kisqali, enables patients to live longer and helps preserve their quality of life. After reviewing said ad, FDA’s Office of Prescription Drug Promotion accused the company of making false or misleading representations about the treatment’s efficacy.


Florida won authorization from the U.S. Food and Drug Administration (FDA) to directly import prescription drugs from Canada, the first state to get such approval for a strategy that could lower prices for medicines.


Chewy Inc was among nine pet companies the U.S. Food and Drug Administration issued warning letters to for selling unapproved animal antibiotics. Their products contain antibiotics such as amoxicillin, penicillin, tetracycline and erythromycin, and are being illegally marketed over the counter, the FDC claims.


A one-month supply of Ozempic, Novo Nordisk A/S’s diabetes drug that’s often used for weight loss, has a list price of $936 in the US, but just $169 in Japan. It’s about ten times more expensive in the US than it is in Sweden.


Withings France SA, Withings Inc, Body Scan Connected Health Station has received FDA approval.

Get on the scale, hold the grab at pelvis height and wait 90 seconds for it to run tests measuring your weight, body fat, muscle mass, visceral fat, ECG, Pulse Wave Velocity, vascular age and nerve health.


3M Co has tentatively agreed to pay more than $5.5 billion to resolve over 300,000 lawsuits claiming it sold the U.S. military defective combat earplugs (regulated as medical devices by the FDA).


The Food and Drug Administration (FDA) is advising people not to buy “Dr. Berne’s MSM Drops 5% Solution” and “LightEyez MSM Eye Drops – Eye Repair,” warning that they could pose a serious health risk, including vision- and life-threatening infections.


A U.S. federal appeals court upheld the Food and Drug Administration’s 23-year-old approval of the widely used abortion pill mifepristone, but said a series of actions the agency took in recent years to make it easier to obtain went too far.


Consumers shouldn’t use certain tests manufactured by Universal Meditech Inc, the U.S. Food and Drug Administration (FDA) warned, including those that test for pregnancy, ovulation and urinary tract infections.


U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings, to make prepaid mail-back envelopes available, for patients to safely and securely dispose of their unused opioid medications, as part of the agency’s comprehensive approach to addressing the overdose crisis.


The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act, allows companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease.


While it is important to limit mercury in the diets of those who are pregnant or breastfeeding and children, many types of fish are both nutritious and lower in mercury.


Human Drugs regulatory activities account for 33 percent of FDA’s budget. However, 65 percent of these activities are paid for by industry user fees.


Animal Drugs and Feeds regulatory activities account for 4 percent of FDA’s budget. But, 22 percent of these activities are paid for by industry user fees.


Biologics regulatory activities account for 7 percent of FDA’s budget, and 42 percent of these activities are paid for by industry user fees.


October 2023 Premarket Notification 510(K) Clearances: 309 Medical Devices



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