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Jul 27, 2026
The U.S. FDA approved Nuzolvence (zoliflodacin), a single-dose oral treatment for uncomplicated urogenital gonorrhea, based on a non-inferiority Phase 3 trial. Thailand also authorized the drug under the brand Nuzolvance, expanding access in low- and middle-income countries.
Jul 27, 2026
NEXT BIOMEDICAL completed an FDA pre-submission review for Nexsphere-F under the TAP program. NexEos Bio received IND clearance to begin a Phase II/III trial of NTX-1024 for vernal keratoconjunctivitis, supported by positive early clinical data.
Jul 26, 2026
New investment models and digital twin technologies are bridging gaps in rare disease drug development, where traditional funding and trial designs fall short. Patient-led funding and family offices provide capital, while regulators accept digital evidence to accelerate therapies for the more than 7,000 rare diseases with few approved treatments.
Jul 25, 2026
A real-world study in Galicia showed nirsevimab reduced RSV-related hospitalizations by 85.9% in the first season and 55.3% in the second. The RSV prevention market is expanding to cover high-risk children, with Beyfortus the only antibody approved for second-season use. The FDA has cited Sanofi for misleading promotional claims about the product.
Jul 25, 2026
The FDA has refused to file Moderna's flu vaccine candidate mRNA-1010. The company will push forward outside the U.S. and pause its combination flu vaccine, while expressing disappointment over the decision's regulatory implications.
Jul 25, 2026
Eli Lilly builds $1.5B stockpile for oral obesity drug orforglipron; study shows GLP-1s cut cancer risk; logistics firms invest in cold chain; and amylin drug race heats up with $19B in deals.
Jul 24, 2026
Lantern Pharma's LP-284 received FDA Orphan Drug Designation for soft tissue sarcomas, while the USPTO allowed a patent for biomarker-guided use of LP-184 in multiple cancers. LP-284 showed a complete metabolic response in a Phase 1 DLBCL patient, and LP-184 demonstrated a 45% disease control rate in advanced solid tumors.
Jul 24, 2026
Eli Lilly will file its triple-agonist obesity drug retatrutide in early 2027 via a Biologics License Application, seeking stronger market protections. Positive Phase 3 results showed up to 22.6% weight loss, while cardiovascular safety data raised some questions.
Jul 23, 2026
The FDA has finalized the revocation of Orange B and proposed revoking Citrus Red No. 2, while exercising enforcement discretion to permit ‘no artificial colors’ claims on foods that avoid petroleum‑based dyes. The actions are part of a broader initiative to phase out synthetic dyes and fast‑track natural alternatives.
Jul 23, 2026
The FDA has alerted medical device manufacturers that the nitrosamine impurity MNP was detected in certain combination products containing rifampin. The agency outlined manufacturer responsibilities for assessing and controlling nitrosamine risks and highlighted available guidance documents.
Jul 22, 2026
The FDA has approved Agios Pharmaceuticals' mitapivat (AQVESME) as the first oral treatment for anemia in thalassemia, reducing transfusion needs by 40-50%. Meanwhile, a clinical trial found a three-times-weekly dosing of vadadustat (Vafseo) is safe for kidney dialysis patients, potentially improving convenience.
Jul 22, 2026
The FDA has agreed to review Moderna's mRNA flu vaccine after initially rejecting it, with a decision expected by August 2026. The reversal occurs amid a contraction in the vaccine sector, with funding drops and layoffs under the Trump administration.
Jul 22, 2026
The FDA proposes to remove three GLP-1 drugs from the bulk compounding list as adverse events near 2,000 and Senator Tom Cotton demands a probe into Chinese APIs in compounded meds. Shortages have largely resolved, but safety and innovation concerns persist.
Jul 21, 2026
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
Jul 21, 2026
Novartis posted Q2 2026 earnings above expectations but a 50% drop in Entresto sales from U.S. generics hurt performance. The company highlighted new EU and Japan approvals for Rhapsido and Itvisma, and a manufacturing restructuring including a German plant closure and investment in radioligand production. A $1.8 billion peptide drug pact with Unnatural Products was also announced.
Jul 19, 2026
The FDA has upgraded a peanut butter recall to Class II after blue plastic fragments were found in a production filter. More than 22,000 single-serve packs from Ventura Foods were distributed to 40 states under various private-label brands. Consumers are advised to check labels and return or discard affected products.
Jul 18, 2026
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Jul 18, 2026
4D Molecular Therapeutics (Nasdaq: FDMT) granted a total of 229,700 restricted stock units to 20 new non-executive hires across three awards in 2026 under its Employment Inducement Award Plan. The grants occurred on February 10, April 14, and July 14, as part of Nasdaq-compliant inducement awards.
Jul 17, 2026
A securities class action lawsuit alleges REGENXBIO misled investors about the safety of its gene therapy RGX-111. Following an FDA clinical hold due to a patient tumor, the stock fell 17.8% in one day. Affected shareholders have until April 14, 2026 to seek lead plaintiff status.
Jul 17, 2026
The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
