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The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The medication is expected to launch in July 2025. REFERENCES 1.
from 2017 to 2020. Authors of a Journal of the American Medical Association study found that adolescent use of GLP-1s “increased substantially” between 2020 and 2023. Dispensing of glucagon-like peptide-1 receptor agonists to adolescents and young adults, 2020-2023. April 2, 2024. Accessed June 25, 2025. 2024;331(23):2041–2043.
Data for the study was gathered from comprehensive administrative health and demographic data in Canada by the Institute for Clinical Evaluative Sciences from January 2020 to November 2023. JAMA Ophthalmol. 2022;140(12):1202–1208. doi:10.1001/jamaophthalmol.2022.4401
Updated October 23, 2020. ClinicalTrials.gov identification: NCT00160108. Updated March 20, 2018. Accessed June 12, 2025. Diet and Body Composition (CENTRAL). ClinicalTrials.gov identification: NCT01530724. Accessed June 12, 2025. Effects of Green-MED Diet Via the Gut-fat-brain Axis (DIRECT-PLUS). Updated July 15, 2019.
1 Natural disasters have reached unprecedented levels in the past 5 years, with 2020, 2023, and 2024 being the most destructive and costly since before 1980. Taking precautions for storing medications and supplies is key to being prepared,” the FDA wrote.
At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.
According to an article in BJOG: An International Journal of Obstetrics and Gynaecology , the rate of pregestational and gestational diabetes has been increasing in the US, occurring in 1% and 8% of all pregnant women in 2020, respectively.
Red raspberry leaves are rich in tannins (a chemical compound) and flavonoids (a plant pigment), which both have antioxidant properties, according to research in Antioxidants journal. In a 2020 study , ellagic acid was shown to inhibit lung cancer cell proliferation and tumor growth. But what about the leaves?
THC acetate esters are different than delta-9-THC, the psychoactive compound found naturally in the cannabis plant. Dr. Boos explained that delta-9-THCO and delta-8-THCO have similar chemical structures and pharmacological activities as compounds in the cannabis plant so they fall within the definition of THC. Terrence L. Boos, Ph.D.,
The guideline states that compounds “at or above the AET must be reported for toxicological risk assessment.” The researchers evaluated DHS extraction performance and compared it to traditional SHS and SBSE GC–MS methods. The paper highlighted that SHS analysis is currently a supplementary technique for volatile analysis.
Solving this before the clinical stage ensures the viability of compounds…” Addressing bioavailability challenges in the first phases of development is essential to help create the most robust product profile and increase the potential for success as small molecule drugs move to the clinic. amorphous solid dispersions, or ASDs.
Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.
The term ‘psychedelic treatments’ incorporates a broad spectrum of different compounds, from LSD, psilocybin and DMT, to MDMA, ibogaine and ketamine. The latter compound has already been approved for treatment-resistance depression as the product Spravato (esketamine), after being developed by Janssen. Paving the way to patients.
Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes. By John W.M. Claud & Sara W.
The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.
The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. 2020 [cited 2023Jan]. 2020; 22(4): 89.
In March 2020, the findings from the trial were published in the New England Journal of Medicine. The US Food and Drug Administration (FDA) has granted Fast Track Designation and Orphan Drug Designation to telacebec. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.
ViiV claimed the latter compound infringes its patents for dolutegravir and other compounds based on the drug’s chemical scaffold. Gilead acquired the drug as part of its $21 billion takeover of Immunomedics in 2020. Gilead now expects product sales in 2022 will be between $23.8 billion and $24.3
In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?
This challenge is further compounded by increasingly complex drug formulations and global ingredient supply chains that stretch manufacturers’ capabilities in testing and control of impurities. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs. Internet] 2023.
Legumes are also great sources of fiber, which is beneficial for gut health, and according to a 2020 study , consuming legumes may help manage blood sugar in people with diabetes mellitus. Also, a diet rich in legumes reduces the risk of diabetes mellitus. This prompted health organizations, including the U.S. For example, 1.5
Summary: • TMP-301 (formerly HTL0014242) is a potent, selective, and orally available mGluR5 negative allosteric modulator (NAM) candidate discovered by Sosei Heptares and out-licensed to Tempero Bio • Phase 1 study in healthy volunteers expected to begin in Q1 2023 with support from a US$5.3M read more.
Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. By Charles D. Snow — Since the U.S. FDCA § 502(ff). What’s to come?
SMi Reports: SMi Group have made the decision due to travel restrictions to open the conference and workshops to all microbiologists by transforming it into a virtual-remote online access event only on October 28 and 29 2020. SMi’s 3rd Annual Pharmaceutical Microbiology East Coast 2020. Conference: October 28th-29th, 2020.
Adults with relapsed or refractory FL with positive tumours for an EZH2 mutation which are detected by an FDA-approved test as well as patients who have previously received at least two systemic therapies are also eligible for the treatment with Tazverik. The boards of directors of both the companies have approved the deal unanimously.
NMR relaxation methods distinguish between components (phases or compounds) that have different molecular mobilities For monoclonal antibodies, identification methodologies can employ chromatography, spectroscopy, isoelectric focusing, capillary electrophoresis and peptide mapping techniques. 2020; 10(1). Cited 2023Feb]. Prullière F.,
Berberine is a yellow alkaloid compound extracted from several plants such as goldenseal, Oregon grape, and tree turmeric. Beyond that, berberine isn’t as effective for weight loss as methods approved by the Food & Drug Administration (FDA). Does berberine help with weight loss?
The FDA approved belimumab (Benlysta), a 200 mg/mL autoinjection, for subcutaneous injection in patients 5 years of age and older with active lupus nephritis who are receiving standard therapy.
Phenylephrine In September 2023, the FDA announced that a common decongestant found on shelves, phenylephrine, is not actually effective to decrease congestion. Some studies suggest curcumin, the active compound in turmeric, may even have antiviral properties. Here’s what to skip. or make an anti-inflammatory chicken soup.
Morphic said it had received notice that Janssen had decided to pull out of the agreement, which initially focused on two targets but was revised at the end of 2020 to with the additional programme covering “antibody activators for an undisclosed integrin target.” In a filing with the Securities and Exchange Commission (SEC).
The European Medicines Agency (EMA) advocates 18 ng/day 6 as the default AI, where the US Food and Drug Administration (FDA) supports a value of 26.5 8 As such, detection of an API nitrosamine with an MDI of 4000 mg/day may be feasible for FDA submissions, but probably not with the EMA. 25 June 2020. EMA/369136/2020.
Foods high in estrogen Phytoestrogens are estrogen-like plant-based compounds and are the form of dietary estrogen obtained from foods we consume. Food and Drug Administration (FDA). Biologically active compounds in selected organic and conventionally produced dried fruits , Foods (2020).
Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory. Garlic Garlic does contain anti-inflammatory compounds that, in theory, might reduce congestion. Eucalyptus is considered toxic to children under two.
The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. 2020, 24 (12), 2915–292. 2020; 24(9): 1558–1585.
The FDA has approved sebetralstat (Ekterly) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age or older, according to a release from KalVista Pharmaceuticals. 1 The decision makes sebetralstat the first and only oral on demand treatment option for the condition.
This allows more of its beneficial compounds to reach the gut, where it can correct gut bacteria imbalances. The National Eczema Foundation points out that the polyphenols, or plant-based compounds in sea moss, may hold many of these benefits, as they’re frequently linked to reducing inflammation (a primary cause of eczema).
Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). We note that in December 2020, the same U.S. By Larry K.
For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. American Diabetes Association (undated) Achieving Type 2 diabetes remission through weight loss , National Institute of Diabetes and Digestive and Kidney Diseases (2020) Carbohydrates.
A 2020 review found that B12 supplementation may improve the effects of antidepressant medication , such as selective serotonin reuptake inhibitors ( SSRIs ). Turmeric Turmeric coupons “Turmeric contains an active compound called curcumin, which has potential benefits, including depression,” Dr. Mandel explains. mcg of B12 daily.
In 2020, Epidiolex was further approved to treat tuberous sclerosis complex (TSC), a rare genetic disorder causing benign brain tumors that can lead to seizures. The FDA approval of Epidiolex is the result of numerous studies in the U.S. This CBD oral solution can be used in adults and children as young as 1 year old.
Stevia is a natural sweetener derived from the plant Stevia rebaudiana , or “honey leaf,” which contains the sweet-tasting compounds known as steviol glycosides. Steviol glycosides, which are refined extracts of stevia, are recognized as safe by the Food and Drug Administration (FDA). doi:10.15344/2456-8007/2020/142. 2020;5:142.
It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. When the news was getting out from China, our virologists in San Francisco were already scanning compounds, seeing which ones were the most effective.
According to a 2020 study, there seems to be a connection between hemorrhoids and Hashimoto’s. [23] Plecanatide : This is one of the newest medications for IBS-C that has been approved by the FDA. Tenapanor : Tenapanor was approved by the FDA in September of 2019 for IBS-C. 78] This makes the stool softer and easier to pass.
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