Regulatory
13 articles in the Regulatory category
Eli Lilly Sets FDA Filing Date for Next Weight-Loss Drug, Pressuring Novo Nordisk
Eli Lilly has officially announced the timing of its FDA filing for its next weight-loss drug, a move that intensifies competitive pressure on Novo Nordisk. The announcement clarifies the regulatory timeline for the highly anticipated treatment.
5 min read
Eli Lilly Sets Retatrutide FDA Filing Date; Stock Target Questioned
Eli Lilly has locked in a U.S. Food and Drug Administration (FDA) filing date for its investigational obesity drug retatrutide, according to a recent report. The news has sparked analyst discussion about whether the company's stock could reach $1,750 by 2027. The filing date marks a key regulatory milestone for the potential blockbuster therapy.
5 min read
FDA Peptide Vote Explained: Why These Drugs Await Approval
A recent FDA advisory vote has left many peptide-based drugs unapproved, raising questions about the regulatory path forward. This article explains the vote's context, the reasons behind the delay, and what it means for developers and patients.
4 min readBachem Holding AG Class B Revenue Breakdown on SIX:BANB
Bachem Holding AG, listed on the SIX Swiss Exchange under ticker BANB for its Class B shares, has published a revenue breakdown. The report, dated August 1, 2026, details the company's financial performance. This analysis provides a clear view of Bachem's revenue streams.
6 min readBachem Stock Under Pressure as Capex Rises and Margins Tighten
Bachem (SWX:BANB) faces margin strain as capital expenditures surge, according to a recent analysis. The report highlights growing financial pressure on the Swiss peptide manufacturer despite its market position. Investors are watching how the company balances expansion with profitability.
6 min readThyroid Meds Recalled Nationwide; GLP-1 Hair Loss Risks and PMOS Data
A nationwide recall of thyroid medications has been announced, affecting multiple brands. New research highlights which GLP-1 drug may carry the highest risk for hair loss. Additionally, prevalence data on postmenopausal ovarian syndrome (PMOS) has been published, offering fresh insights into this condition.
5 min read
FDA Urged to Reject Untested Peptides in Compounded Medications
The Information Technology and Innovation Foundation (ITIF) published a blog on July 22, 2026, arguing that the FDA should not allow untested peptides to be added into patients' medications. The piece warns that adding unapproved peptides to compounded drugs poses serious safety risks without proven benefits, and calls for stronger regulatory oversight to protect public health.
5 min read
Cenna Biosciences Gets FDA Nod for Alzheimer's Peptide Trial
Cenna Biosciences has received FDA clearance to begin a Phase 1a/1b clinical trial of 8M2D, a first-in-class peptide designed to stop amyloid production in Alzheimer's disease. The regulatory green light marks a key step toward testing the novel therapeutic in humans.
2 min readIs Tirzepatide Better Than Semaglutide for Weight Loss? Comparison
A comparison examines if Tirzepatide outperforms Semaglutide for weight loss. The two drugs are directly contrasted on this measure. This regulatory news covers the key question of superiority.
2 min read
FDA Eyes Lifting Restrictions on Cosmetic Peptides
The FDA shows signs of reevaluating restrictions on cosmetic peptides like GHK-Cu and SNAP-8, which face limits in compounding pharmacies despite use in low-concentration skincare products. These compounds offer benefits in skin rejuvenation and wound healing but remain on restricted lists under Section 503A. Recent agency feedback requests hint at possible changes to improve access.
3 min readFDA Shake-Up and Growing Frustration with Prior Auth Reform
A shake-up is taking place at the FDA. Frustration continues to grow over prior auth reform. These regulatory matters affect pharmaceutical operations and draw attention from industry participants. The combination of the FDA shake-up and prior auth reform issues forms a central focus in current discussions. Observers note both elements as active concerns.
1 min readRoche Secures CE Mark for Second Eli Lilly Alzheimer’s Test
Roche has obtained a European CE mark for its second Alzheimer’s test developed with Eli Lilly. The diagnostic can confirm the disease or rule it out. This approval enables use across Europe for better patient assessment.
2 min read
GLP-1 Agonists Linked to Better Breast Cancer Survival Signals
A large retrospective study in JAMA Network Open links GLP-1 receptor agonist use to improved survival and recurrence outcomes in women with breast cancer, obesity, or type 2 diabetes. The analysis from 841,831 patients shows strong hazard ratios, such as 0.35 for mortality in obesity cases. Observational data raises questions about causality and confounding.
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