Friday, June 5, 2026
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL
Thursday, June 4, 2026
FDA Grants Orphan Drug Designation for Tinostamustine in Malignant Glioma
Purdue Pharma L.P. (“Purdue”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pipeline drug tinostamustine for the treatment of malignant gliomas, a broad category of brain and spinal cord cancers that affect both adults and children and includes rapidly growing, invasive tumors like glioblastoma. As many as 22,000 people are diagnosed with malignant gliomas annually in the United States1. FDA grants ODD status to encourage development of promising medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
Purdue is currently investigating tinostamustine in patients with glioblastoma, the most common malignant glioma, that is aggressive, very challenging to treat and for which there is no cure.2 Most patients do not survive more than 15 months with current treatment approaches.3 The ODD request for tinostamustine was supported by robust epidemiologic, clinical and pre-clinical evidence, as well as mechanistic rationale supporting its potential to address a critical unmet medical need for glioblastoma.
“As many as 15,000 people in the U.S. are diagnosed with glioblastoma each year.3 Unfortunately, there is limited survival benefit with existing treatment options,” said Julie Ducharme, Vice President and Chief Scientific Officer, Purdue. “This recognition from FDA is an important milestone in our mission of advancing innovative science in areas of serious, unmet medical need. We look forward to further investigating tinostamustine, which has shown promise in early trials.”
Orphan drug designation is intended to facilitate drug development for rare diseases and may provide certain incentives to drug developers.4,5 These benefits include tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential for seven years of market exclusivity following approval.
Tinostamustine is a potential first-in-class, new chemical entity that combines two potentially synergistic mechanisms of action, bifunctional alkylating activity and pan histone deacetylase inhibition (or HDAC inhibition). Tinostamustine has the potential to be a first-line treatment for glioblastoma.
“Behind every designation like this are real people, patients and families, facing the devastating reality of malignant gliomas, especially glioblastoma,” said Craig Landau, MD, President and CEO, Purdue Pharma. “We are deeply committed to pursuing this medicine that has the potential to bring hope where few options exist today. Tinostamustine represents a step forward in our efforts to help address the urgent and unmet needs of those affected by these aggressive cancers.”
The Company also recently entered into an agreement with the Global Coalition for Adaptive Research (GCAR) to pursue the Phase 2/3 clinical development of tinostamustine in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), a global adaptive platform trial for glioblastoma.
This press release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that tinostamustine will successfully complete development or gain FDA approval.
Wednesday, June 3, 2026
Icotrokinra Beneficial for Adults, Teens With Plaque Psoriasis
For adults and adolescents with moderate-to-severe plaque psoriasis, selective blockade of the interleukin-23 receptor with the targeted oral peptide icotrokinra yields a significantly higher incidence of skin clearance at week 16 than placebo, according to a study published in the Nov. 6 issue of the New England Journal of Medicine.
Robert Bissonnette, M.D., from Innovaderm Research in Montreal, and colleagues conducted a phase 3, randomized trial involving adults and adolescents (aged 12 years and older) with moderate-to-severe plaque psoriasis. Participants were randomly assigned to receive either icotrokinra (200 mg once daily through week 24) or placebo through week 16 followed by transition to icotrokinra (456 and 228 patients, respectively).
The researchers found that 65 percent of the participants receiving icotrokinra and 8 percent of those receiving placebo had an Investigator's Global Assessment (IGA) score of 0 or 1 with ≥2-point reduction from baseline at week 16, and 50 and 4 percent, respectively, had a ≥90 percent reduction from baseline in the Psoriasis Area and Severity Index (PASI) score. At week 16, complete clearance of skin was significantly more likely with icotrokinra than placebo (IGA score 0: 33 versus 1 percent; 100 percent reduction from baseline in the PASI score: 27 versus 1 percent). In each group, 49 percent of patients had at least one adverse event through week 16.
"Once-daily icotrokinra, a systemic targeted oral peptide binding to the interleukin-23 receptor, was effective for treating plaque psoriasis in adults and in adolescents, an age group with limited systemic treatment options," the authors write.
Tuesday, June 2, 2026
FDA Approves Clotic (clotrimazole otic solution), First Treatment with Clinical Evidence for Fungal Ear Infections
In continuation of my update on clotrimazole
Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Administration (FDA) has approved Clotic (clotrimazole otic solution), the first and only treatment with clinical evidence specifically indicated for fungal otitis externa (otomycosis).
About Clotic
Clotic is a broad-spectrum otic antimycotic agent containing clotrimazole, an azole antifungal that inhibits fungal enzyme production essential for survival. The medication works by blocking cytochrome P450-dependent enzymes, damaging fungal cell walls and disrupting growth, ultimately causing cell death. This preservative-free formulation is administered as ear drops using innovative Blow-Fill-Seal technology in single-dose vials.
Clotic is indicated for the treatment of fungal otitis externa (otomycosis) in adults 18 years of age and older, specifically targeting infections caused by Aspergillus species and Candida species. The treatment is approved only for patients with intact tympanic membranes.
The FDA approval of Clotic was based on comprehensive clinical data demonstrating well-recognized safety and efficacy in treating pathogenic dermatophytes, yeasts, and several species of fungus affecting the outer ear canal. The approval package included analytical and clinical evidence supporting Clotic's effectiveness as the first clinically proven treatment option for otomycosis.
Clotic is administered twice daily for 14 days, with each single-dose vial (1%/0.17mL) delivering the complete treatment dose. The innovative packaging protects the preservative-free formulation from humidity and contamination while ensuring precise dosing.
The approval of Clotic marks an important milestone in addressing an underserved therapeutic area, offering the first FDA-approved treatment specifically designed and clinically validated for fungal otitis externa in adult patients.
Monday, June 1, 2026
Bictegravir and lenacapavir: What is it and is it FDA approved?
Saturday, May 30, 2026
Tomato-Soy Juice Shows Promise Against Chronic Inflammation
Friday, May 29, 2026
Could guava juice help prevent anemia?
A systematic review from Indonesia, published in the journal BMJ Nutrition, Prevention & Health, indicates that adding guava juice to the diet could boost hemoglobin levels in adolescent girls and pregnant women. This could potentially offer a low-cost dietary complement to iron supplementation, given the high prevalence of iron-deficiency anemia among females, especially in low- and middle-income countries (LMICs).
Iron deficiency anemia among young women
In 2021, anemia was estimated to affect about 45 % of pregnant women and 39.5 % of non-pregnant women worldwide. Indonesia had similar figures: 48.9 % among pregnant women and 32 % among adolescent girls. Women with severe anemia are twice as likely to die during pregnancy and postpartum, compared to those with mild anemia.
Iron deficiency is the primary cause of anemia, especially in LMICs. The reasons include poor dietary intake, high prevalence of infection, heavy bleeding during periods, frequent pregnancies, and low healthcare access.
Iron deficiency anemia is conventionally treated with iron supplementation, but oral iron can cause symptoms such as diarrhea or constipation, other gut symptoms, an unpleasant taste, and may be inaccessible to some women. Pregnancy can further complicate treatment, as physiological changes may decrease iron absorption during this period.
This has resulted in persistently low use of iron supplements, even with national nutritional programs like the Gerakan Nasional Aksi Bergizi or iron supplementation programs targeting pregnant women and adolescent girls.
Nutritional benefits of guava
Guava is a locally cultivated and inexpensive fruit. Its juice is rich in vitamin C, folate, antioxidants, flavonoids, and polyphenols, and other micronutrients. The current study aimed to examine the potential of guava juice as a natural adjunct to iron therapy.
Guava juice and iron supplements
This systematic review and meta-analysis included 17 Indonesian studies published between 2019 and 2024, with a total of 726 participants. Most studies were quasi-experimental, while two were randomized controlled trials (RCTs). The participants were pregnant women or adolescent girls, with numbers ranging from 15 to 230.
While the findings were encouraging, most of the evidence came from relatively small quasi-experimental studies rather than randomized trials
Most studies evaluated guava juice alongside iron supplementation, while a few used it alone or in combination with carrot or red spinach juice. Intervention periods ranged from five days to three months.
Eight studies compared guava juice plus iron supplementation with iron supplementation alone, although only five of these provided extractable data for the direct comparative meta-analysis. One study used papaya juice and another dragon fruit juice as comparators. The remaining seven studies had no control group.
The meta-analysis was limited to 12 studies because the others lacked usable data. The results were promising, consistently indicating a significant average increase of 1.7 g/dL in hemoglobin among pooled participants who consumed guava juice.
When stratified by participant type, adolescents had a mean improvement in hemoglobin levels of 1.5 g/dL, versus 1.8 g/dL among pregnant women.
Across five studies that directly compared guava juice interventions with iron-only controls, hemoglobin levels increased by an additional 1.3 g/dL on average in the guava juice groups. This was confirmed to be robust by sensitivity analyses, with little evidence of publication bias.
Possible physiological pathways
The degree of improvement in hemoglobin observed by the researchers is substantial enough to potentially move some individuals with mild or moderate anemia into non-anemic categories. Other experimental studies involving male athletes, anemic schoolchildren, and postpartum women have shown similar positive effects from both guava juice and guava fruit consumption.
This suggests the beneficial impact of guava’s high vitamin C and polyphenol content, irrespective of the form of consumption. Vitamin C improves the absorption of iron from non-heme sources, including iron supplements, by converting ferric iron into its more absorbable ferrous form.
Guava also contains folate, antioxidants, flavonoids, and polyphenols that may support red blood cell survival by reducing oxidative stress. The researchers suggest that juice preparation may improve compliance and could enhance nutrient availability, while promoting more consistent intake.
Study limitations
Despite the promising results, the review also noted limitations. All studies were conducted in Indonesia, limiting generalizability to other populations. Many studies had a moderate risk of bias, sample sizes were relatively small, and most were non-randomized designs. Missing data also reduced the size of the meta-analysis. The studies showed high heterogeneity due to differences in guava dosage, preparation, and duration.
Future follow-up research should include larger, well-designed RCTs across multiple countries with standardized reporting, including regimens and outcomes. These should include not only hemoglobin but also parameters such as transferrin and ferritin that reflect broader health impacts and long-term effectiveness. This would help identify the optimal dosage, dosing frequency, and duration of use.
Implementation research is also required to understand how far such an intervention could be embedded into existing programs, supporting its real-world relevance.
Conclusion
Overall, the study concludes that guava juice significantly improves hemoglobin levels in women and adolescent girls. The authors highlight the potential of guava juice as an affordable, culturally acceptable, and locally available dietary adjunct to iron supplementation and anemia prevention programs in resource-limited settings.
It is particularly relevant in tropical countries with high guava production, such as India and Indonesia. The authors suggest integrating guava juice into school nutrition programs, antenatal care packages, and community health initiatives.
This could be a sustainable, complementary strategy to prevent and treat mild-to-moderate anemia, aligning with the United Nations’ Decade of Action on Nutrition (2016–2025) and its dietary emphasis on local foods.
FDA Approves Rhapsido (remibrutinib) for the Treatment of Chronic Spontaneous Urticaria
Wednesday, May 27, 2026
FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water Restrictions
Monday, May 25, 2026
Vitamin C may reduce cancer-linked digestive chemical reactions
In continuation of my update on Vitamin C
A new study from the University of Waterloo uses mathematical modeling to examine how Vitamin C affects chemical reactions in the digestive system that are linked to cancer development.
Over the last several decades, North American diets have seen a steady increase in exposure to nitrates and nitrites: compounds found in cured meats as well as fruits and vegetables grown using polluted soil and water. While nitrates and nitrites play important roles in neurological and heart health, in the stomach, they can undergo a chemical reaction known as "nitrosation" and form chemicals that many scientists suspect increase cancer risk.
Since at least the 90s, researchers have been studying the link between cancer and these compounds, with conflicting results. Our work suggests that the presence of dietary Vitamin C may help explain these inconsistencies."
Dr. Gordon McNicol, post-doctoral researcher in applied mathematics and first author of the study
The team built a mathematical model of the salivary glands, stomach, small intestine and plasma, and simulated how nitrites and nitrates move through the body and change over time. Their model demonstrated that when Vitamin C is also present in food, such as leafy greens like spinach, which contain both Vitamin C and nitrate, it could decrease cancer risk.
The study also suggested that taking Vitamin C supplements after each meal could have a moderate positive effect in reducing the formation of nitrosation products associated with cancer risk from dietary nitrites and nitrates, such as those found in foods like bacon and salami.
The researchers hope these findings will support future nutrition research.
"This work provides a mechanistic roadmap for future clinical and laboratory studies by identifying the key interacting drivers of these potentially harmful chemical reactions, including nitrite exposure, antioxidant intake, meal timing, gastric conditions and oral microbiome activity," said Dr. Anita Layton, professor of applied mathematics and Canada 150 researcher chair. "This model can help researchers design more targeted experiments and interventions, focusing on when and in whom nitrosation is most likely to occur."
The research, "Vitamin C as a nitrosation inhibitor: A modelling study across dietary patterns and water quality," appears in the Journal of Theoretical Biology.
Thursday, May 21, 2026
FDA Approves Lasix ONYU (furosemide) for Treatment of Edema in Heart Failure
Wednesday, May 20, 2026
FDA Approves Jascayd (nerandomilast) to Treat Idiopathic Pulmonary Fibrosis
Tuesday, May 19, 2026
Mavacamten improves obstruction in adolescents with hypertrophic cardiomyopathy
"These results are very encouraging," said Joseph William Rossano, MD, chief of cardiology at Children's Hospital of Philadelphia and the study's lead author. "Patients feel better, and their hearts look better."
HCM is a genetic disorder in which the heart muscle thickens, causing the heart chambers to become smaller and potentially reducing its ability to pump blood. In many cases, the thickened muscle blocks or reduces the flow of blood into the aorta from the left ventricle, known as obstructive HCM. Obstructive HCM can cause symptoms such as chest pain, dizziness, shortness of breath and swelling and lead to heart failure and death.