Peptide Regulation & FDA News

The FDA has granted accelerated approval to Bristol Myers Squibb's iberdomide, marketed as Zenbexus, for relapsed or refractory multiple myeloma in combination with dexamethasone and daratumumab. As a first-in-class CELMoD agent, iberdomide is a cereblon-modulating peptide-like molecule that induces targeted protein degradation to eliminate cancer-driving proteins. The approval was supported by Phase 3 data showing a statistically significant improvement in minimal residual disease-negative complete response rates compared to standard care.

Novo Nordisk has announced two major regulatory milestones in the European Union. The company received approval for an oral version of its weight management drug Wegovy, as well as a new 7.2 mg dose pen. Additionally, the company is taking legal action against Eli Lilly regarding misleading GLP-1 advertising campaigns.

The FDA has granted accelerated approval to Novo Nordisk’s Wegovy (semaglutide) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This decision is based on Phase 3 data from the ESSENCE trial, where the drug significantly outperformed placebo in resolving liver inflammation and improving scarring. Wegovy is now the first GLP-1 receptor agonist approved for this liver condition.

The FDA has approved Novo Nordisk's once-weekly GLP-1 receptor agonist Ozempic (semaglutide) to improve glycemic control in adults with type 2 diabetes. Based on the SUSTAIN Phase 3a clinical trial program involving over 8,000 adults, the drug demonstrated superior A1c reductions compared to sitagliptin and exenatide extended-release, as well as significant weight loss as a secondary benefit. The drug will be available in 0.5 mg and 1 mg pre-filled pen doses.

Medivir has received a Notice of Allowance from the US Patent and Trademark Office for a patent covering the combination of its peptide prodrug fostrox and lenvatinib for treating liver cancers. This approval strengthens the company's intellectual property position in the US market, extending potential market exclusivity for this combination therapy until at least 2041.

The FDA has officially reversed its decades-old stance on menopausal hormone therapy, announcing the removal of black box warnings regarding cardiovascular, dementia, and breast cancer risks. Commissioner Marty Makary stated that the agency now recognizes the treatments offer significant benefits for heart, brain, and bone health. This decision revises the labeling requirements for estrogen and progestogen products to reflect a more nuanced, evidence-based understanding of their safety profile.

The CDC has recommended the use of a lab-made antibody, nirsevimab, as a primary option to protect newborns from severe RSV. This single-dose injection is approved for infants younger than 8 months entering their first RSV season. The agency also endorsed a maternal vaccine strategy, creating two distinct immunization pathways to guard infants against the respiratory virus.

An FDA advisory panel has voted to narrowly reject the compounding of tirzepatide while narrowly backing the compounding of semaglutide and another GLP-1 drug. This decision comes as the FDA faces political pressure from the Trump administration and Robert F. Kennedy Jr. to increase access to these weight-loss medications. The votes reflect a contentious debate between FDA staff warning about safety risks and peptide enthusiasts advocating for broader availability.

The FDA has approved an oral version of Novo Nordisk’s Wegovy for weight loss and cardiovascular risk reduction. Clinical trials showed the pill achieves similar efficacy to the injectable form, with patients losing approximately 14% of their body weight. This approval marks the first time a GLP-1 pill has been cleared for obesity, potentially increasing access for those averse to injections.

An FDA advisory panel has voted to allow compounding pharmacies to produce copies of certain popular peptide-based weight loss and diabetes drugs, specifically tirzepatide, semaglutide, and retatrutide, during periods of drug shortage. The panel rejected a proposal to allow compounding for a fourth peptide. This decision is a significant victory for the compounding industry and patients seeking lower-cost alternatives, but it raises safety concerns among FDA staff regarding the quality of non-FDA approved versions.

The FDA has issued over 50 warning letters to telehealth companies and medical spas regarding the marketing of compounded GLP-1 obesity drugs. The letters target providers for making false or misleading claims, specifically implying that these compounded versions are identical to FDA-approved branded medications. This action is part of a broader Department of Health and Human Services initiative to regulate direct-to-consumer drug advertising.

The FDA issued a warning letter to ImmunityBio and founder Patrick Soon-Shiong for making false and misleading claims regarding their cancer therapy, Anktiva. The agency criticized the company for suggesting the drug treats 'all cancers' without evidence, failing to disclose required combination use with a vaccine, and downplaying serious risks. The FDA also challenged claims that the treatment renders patients 'cancer free,' stating that such assertions are not supported by clinical data.

An FDA advisory panel has voted to allow the compounding of tirzepatide and semaglutide, major GLP-1 agonists used for weight loss and diabetes, while rejecting a petition for a third peptide. This decision is a significant victory for the compounding industry and patients seeking lower-cost alternatives to branded drugs like Mounjaro and Zepbound, though it bypasses standard safety approvals.

Sanofi has formally requested that the FDA remove its type 1 diabetes drug, teplizumab, from Commissioner Marty Makary's expedited review program. This request follows an unusual intervention by acting CDER director Tracy Beth Høeg, who reportedly overruled career staff scientists regarding the drug's approval. The agency subsequently missed its decision deadline, raising concerns about political interference in the scientific review process.

After a multi-year pharmacovigilance review triggered by a 2024 WHO VigiBase disproportionality signal, the FDA concluded that GLP-1 receptor agonists (semaglutide, tirzepatide, liraglutide, and related drugs) do not increase the risk of suicidal ideation or behavior and formally requested manufacturers remove the related warning labeling. The finding aligns with a parallel European Medicines Agency (EMA) review that likewise found no causal link. Large 2025 cohort studies and meta-analyses published in BMJ and other journals consistently showed no elevated suicide risk versus comparator drugs. The episode illustrates how spontaneous-report databases can flag signals that controlled analyses later rule out.

On February 21, 2025, the FDA determined that the national shortage of injectable semaglutide (Ozempic/Wegovy) was resolved and removed it from the drug-shortage list, triggering a phased wind-down of pharmacy compounding. State-licensed 503A compounding pharmacies generally lost their shortage-list exception by April 22, 2025, and FDA-registered 503B outsourcing facilities had until May 22, 2025 to cease production. The move mirrors the earlier resolution of the tirzepatide shortage and re-establishes that Novo Nordisk's branded products are the only FDA-approved semaglutide injectables. A pending court challenge left narrow enforcement discretion for some 503A operations, but the policy direction is settled: mass compounding of semaglutide is ending as branded supply catches up with demand.

On July 23–24, 2026, the FDA's Pharmacy Compounding Advisory Committee recommended adding six of seven reviewed peptides (BPC-157, KPV, TB-500, MOTS-c, Epitalon, Semax) to the Section 503A Bulks List and rejected Emideltide/DSIP. The vote is advisory only — not a final FDA decision and not legal authorization to compound. FDA must still complete formal notice-and-comment rulemaking (typically 12–24 months) before any change in legal status.

A federal advisory panel has narrowly voted to recommend easing FDA restrictions on the compounding of specific peptides, including BPC-157 and TB-500. This advice, which is not binding, contradicts FDA scientists who warn of insufficient safety and efficacy data. The decision aligns with the views of Health Secretary Robert F. Kennedy Jr. and could lead to increased availability of these substances through telehealth and compounding pharmacies.

The FDA has announced the agenda for the July 2026 meeting of the Pharmacy Compounding Advisory Committee (PCAC). The committee will review specific bulk drug substances, including BPC-157 and KPV, for potential inclusion on the 503A Bulks List. This meeting represents a critical regulatory step toward determining the legal status of these peptides for pharmacy compounding.

The FDA has approved enlicitide, marketed as Lipfendra, as the first oral PCSK9 inhibitor for treating hypercholesterolemia. Unlike existing injectable therapies in this class, this new drug offers a once-daily tablet option to lower LDL cholesterol in adults who require additional reduction beyond diet and maximally tolerated statins. Clinical trials involving over 3,200 patients demonstrated the drug's efficacy and safety profile.

The European Commission has approved Novo Nordisk's oral semaglutide 25 mg tablet (Wegovy pill) for weight management, marking the first oral GLP-1 receptor agonist available in the EU. The approval is for adults with obesity or overweight with comorbidities. Additionally, the EC approved a 7.2 mg single-dose pen injection. Novo Nordisk plans to launch the tablet in the EU in the second half of 2026.

Across 2025-2026 the FDA's Office of Compliance issued a string of warning letters to internet peptide retailers - including USApeptide.com (February 2025), Gram Peptides (March 2026), and Wholesale Peptide (June 2026) - alleging they are selling unapproved new drugs in violation of Section 505(a) of the FD&C Act. The letters single out products marketed for healing, recovery, and research that the agency says carry disease-treatment claims triggering drug status. Named substances include BPC-157, TB-500 (thymosin beta-4), CJC-1295, ipamorelin, and GHK-Cu. The enforcement runs in tension with the July 2026 PCAC vote recommending several of these same peptides for the 503A compounding list, but legally the two tracks are separate.

The FDA has approved the first oral pill version of Wegovy for weight management. The pill contains semaglutide, the same active ingredient found in the injectable form and other GLP-1 agonists. Experts believe this new daily pill formulation will improve patient adherence by eliminating the barrier of needle phobia and normalizing obesity treatment similar to hypertension management.

Cidara Therapeutics has received U.S. FDA Breakthrough Therapy designation for CD388, a long-acting antiviral conjugate designed for the prevention of seasonal influenza A and B. This regulatory milestone is supported by Phase 2b data showing statistically significant prevention of flu in healthy adults and targets high-risk populations who respond poorly to vaccines. The company is accelerating the development of CD388, with a Phase 3 trial now underway ahead of schedule.

The FDA established a 'green list' import alert on September 5, 2025 to block GLP-1 active pharmaceutical ingredients from unverified foreign sources. Facilities inspected and found compliant will be listed, while all other GLP-1 APIs face detention without physical examination. The action targets the surge in illegal compounded semaglutide and tirzepatide, which the agency links to dosing errors and adverse events.

In December 2024 the FDA approved Eli Lilly's Zepbound (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity - the first prescription medicine ever cleared for the sleep disorder. The indication was supported by two randomized, placebo-controlled SURMOUNT-OSA trials showing reductions in apnea-hypopnea events and body weight. The approval expands the peptide-based GLP-1/GIP agonist franchise beyond diabetes (Mounjaro) and obesity (Zepbound) into a cardiometabolic comorbidity that affects tens of millions of Americans, and it positions tirzepatide as a disease-modifying therapy rather than a cosmetic weight-loss drug.

The FDA sent warning letters to five companies for selling unapproved GLP-1 peptide products, including semaglutide, tirzepatide, and retatrutide, in interstate commerce. One company, Veronvy, was cited for misbranded oral GLP-1 products falsely claiming FDA approval. The letters target peptide vendors Xcel Peptides, Swisschems, Summit Research, and Prime Peptides. This is part of ongoing FDA enforcement against unapproved GLP-1 sales amid high demand for these drugs.

The FDA issued a warning letter to Peak Performance Peptides, an online seller, for marketing unapproved injectable peptide drugs including retatrutide, semaglutide, PT-141, tesamorelin, and SS-31 via its website. The agency stated these products are unapproved new drugs under the FD&C Act and warned of possible seizure or injunction if violations are not corrected. The letter highlights ongoing FDA scrutiny of grey-market peptide sellers.

The FDA issued a warning letter to TXP Innovations LLC (dba Tex Peptides) after reviewing its website in July 2026 and finding it marketed unapproved injectable peptide drugs, including semaglutide, tirzepatide, retatrutide, SS-31 (elamipretide), tesamorelin, and PT-141 (bremelanotide). The agency deemed these unapproved new drugs under section 505(a) of the FD&C Act. The letter warns that continued violations could trigger seizure or injunction. It underscores FDA's ongoing crackdown on unapproved peptide products sold directly to consumers online.

The FDA issued a warning letter to Peptide Partners LLC for marketing unapproved peptide drugs, including semaglutide, tirzepatide, retatrutide, elamipretide, tesamorelin, and PT-141, via its website. The agency stated these products violate the Federal Food, Drug, and Cosmetic Act as unapproved new drugs. The letter highlights the risks of injectable unapproved products and warns of potential seizure or injunction if violations persist.

The FDA has finalized a guidance document outlining its enforcement discretion policy for dietary supplements containing N-acetyl-L-cysteine (NAC). While the agency maintains that NAC is legally excluded from the dietary supplement definition because it was approved as a drug prior to being marketed as a supplement, it will not prioritize enforcement against compliant products. This policy allows lawfully marketed NAC products to remain on the market pending the completion of a future rulemaking process.

The FDA has approved icotrokinra, marketed as Icotyde, as the first oral peptide treatment for moderate to severe plaque psoriasis in adults and adolescents. Developed by Johnson & Johnson, the drug works by blocking the interleukin-23 (IL-23) receptor. This approval provides a new systemic option for patients aged 12 and older who weigh at least 40 kg, addressing a historical gap in oral therapies that balance efficacy with safety.

The FDA has approved a new subcutaneous formulation of the cancer immunotherapy nivolumab, co-formulated with the peptide enzyme hyaluronidase-nvhy, under the brand name Opdivo Qvantig. This approval allows for injection under the skin rather than intravenous infusion across all solid tumor indications for adults. Clinical trials confirmed that the subcutaneous method provides comparable drug exposure and safety to the traditional IV infusion.

The FDA's Center for Research on Complex Generics (CRCG) is hosting a two-day hybrid workshop in September 2026 focused on navigating the regulatory pathway for generic GLP-1 drugs. This initiative is part of a broader effort to address the scientific challenges associated with approving complex generic medicines, which often lack market competition due to difficult bioequivalence requirements.