Articles by tag: fda-approval
FDA approved the first ophthalmic bevacizumab LYTENAVA for the treatment of wet AMD
FDA accepted Outlook Therapeutics' appeal and will approve LYTENAVA — a standardized bevacizumab for neovascular AMD. Analysis of consequences for the anti-VEGF market, pricing, and patients. Read more.
CRISPR vision restoration: FDA approval for testing
A US startup received FDA approval to test CRISPR therapy for people born blind with Leber congenital amaurosis. Details, risks, and prospects in the article.
ZAYNICH antibiotic: FDA approval for urinary tract infections
FDA approved antibiotic ZAYNICH (cefepime+zidebactam) for complicated urinary tract infections. Efficacy 89% vs 68% for meropenem. Learn about the breakthrough in combating resistance.
Zuranolone for postpartum depression: FDA approval 2026
Analysis of FDA approval of the first oral drug for PPD — zuranolone. Who won and lost, why it was denied for MDD, price, efficacy. Read more.
FDA approved Imfinzi: first immunotherapeutic combination for bladder cancer
FDA approved Imfinzi (durvalumab) + BCG for high-risk non-muscle-invasive bladder cancer. 32% reduction in recurrence risk. Learn about the breakthrough in oncourology.
Universal CAR-T therapy: FDA allows trials for autoimmune diseases
FDA approved clinical trials of allogeneic CAR-T cell therapy QT-019C for lupus and scleroderma. Savings up to $100 billion, no chemotherapy. Learn about the breakthrough.
RNA interference-based drug for hyperlipoproteinemia(a) approved by FDA
FDA approved the world's first siRNA drug to reduce lipoprotein(a) by more than 80%. Learn about the mechanism of action, efficacy, and impact on cardiology. Read details.
Johns Hopkins AI sepsis early warning system approved by FDA: 18% mortality reduction
FDA approved Target Real-Time Early Warning System — the first AI for detecting sepsis before clinical suspicion. 18% mortality reduction, up to 48 hours saved. Learn how it changes care standards.
ADC drug Decnupaz: treatment of ultra-rare blood cancer BPDCN
FDA approved pivekimab sunirin (Decnupaz) for BPDCN with complete remission of 69.7%. Analysis of efficacy, risks, price, and prospects in AML. Read more.
CAR-T therapy for lupus: FDA approval 2026
Analysis of FDA approval of the first CAR-T cell therapy for severe lupus. Key players, forecasts, and hidden risks. Find out who is leading the race.
Targeted therapy for ultra-rare blood cancer: FDA approves pivekimab sunirin
FDA has registered the first targeted therapy for BPDCN — pivekimab sunirin. Remission rate 69.7%, but there are risks. Detailed analysis of the drug and consequences.
FDA approval of combination immunotherapy for bladder cancer: durvalumab + BCG
FDA approved durvalumab with BCG for high-risk NMIBC. POTOMAC data: 32% risk reduction. Analysis of efficacy, toxicity, and consequences of BCG shortage. Learn more.
FDA approved AI early sepsis warning system from Johns Hopkins
FDA approved TREWS — the first AI system for early sepsis detection from Johns Hopkins. Mortality reduction by 18%. Learn how the technology is changing screening standards.
FDA approved bulevirtide (Hepcludex): treatment of hepatitis delta in the USA
FDA approved the first US drug for hepatitis delta — bulevirtide (Hepcludex). Learn about dosage, risks, price, and prognosis. Read the full analysis.
FDA approved Differin Epiduo over-the-counter: combination gel for acne
Learn how FDA approved the first over-the-counter gel Differin Epiduo (adapalene+benzoyl peroxide) for treating acne in adolescents and adults. Price, benefits, risks — read in the analysis.
Bulevirtide (Hepcludex®): FDA approval for hepatitis D
FDA approved the first drug for chronic hepatitis D — bulevirtide. Mechanism, doses, risks, price, and prognosis. Find out who is suitable for therapy.
FDA-approved antibiotic resistance test for vaginal microbiome
FDA approved the first 15-minute test for lactobacillus resistance to clindamycin and metronidazole. Learn how this will change the treatment of bacterial vaginosis and who will benefit from the new diagnostics.
FDA approved AI system for early sepsis warning TREWS
Analysis of FDA approval of the first AI system for early sepsis warning: TREWS reduces mortality by 20%, changes the hospital analytics market. Read the full analysis.
Marne-Cel FDA approval: gene therapy for LAD-I
FDA approved Marne-Cel for children with severe LAD-I: 100% survival in trials. Learn how Rocket Pharmaceuticals turned rejections into a breakthrough.
Pediatric Dovato: ViiV application and geopolitics of the HIV market
ViiV has submitted applications to the FDA and EMA for dispersible Dovato tablets for children. We analyze the strategy, patents, and implications. Find out who will win.
Breakthrough Prize 2026 Laureates: Gene Therapy and CRISPR
Analysis of Breakthrough Prize 2026 Laureates: How FDA-Approved Gene Therapy and CRISPR Editing Became a New Business Model and What Awaits ALS Therapy. Learn About the Main Trends.
Abbott Ultreon 3.0: AI platform for stenting
FDA approved Abbott Ultreon 3.0 — the first AI platform for real-time stenting. Evaluate the benefits for cardiologists and patients with CKD.
FDA approved a calibration-free finger blood pressure monitor
FDA approved Biozen BP1000 — the first calibration-free fingertip blood pressure monitor. Learn how this will change the hypertension market and your health. Read the analysis.
FDA approved AI for sepsis detection: mortality -18%
FDA approved Bayesian Health: the first AI system for early sepsis screening. Data, insights, and market forecast. Learn how the technology is changing treatment standards.
Fasenra approved by FDA for treatment of hypereosinophilic syndrome
FDA approved Fasenra (benralizumab) for HES therapy. 65% reduction in exacerbation risk and steroid-sparing effect. Learn how this changes the biosimilar market.
FDA approved INQOVI + venetoclax: oral therapy for AML
FDA approved the first fully oral regimen for unfit AML. Learn how the INQOVI+venetoclax combination is changing treatment and quality of life. Details and market outlook.
FDA approves expansion of Avastin biosimilar production
FDA approves expansion of Avzivi biosimilar production to 4000 L. Learn how this will lower bevacizumab prices and reshape the market. Detailed analysis.
Gene therapy for OTOF deafness: hearing restoration
FDA approved the first gene therapy for hereditary deafness Otarmeni. Learn how a single injection restores hearing in OTOF mutation and changes the market.
Teplizumab approved for children: delaying type 1 diabetes
FDA approved teplizumab for children from 1 year old. Learn how disease-modifying therapy changes the treatment paradigm for type 1 diabetes. Detailed analysis.
Anifrolumab in autoinjector: FDA approves home treatment for lupus
FDA approves Saphnelo Pen for home treatment of lupus. Learn how the anifrolumab autoinjector is changing therapy and reducing access barriers. Details and forecasts.
Islatravir: New HIV Pill Approved by FDA
FDA approved Idvynso (doravirine/islatravir) — the first two-drug regimen without INSTI and tenofovir. Learn why this is a new standard of therapy for aging HIV patients. Read details.
Vepdegestrant: FDA approved the first PROTAC degrader
FDA approved Vepdegestrant — the first protein degrader tablet for ESR1-mutant breast cancer. PFS 5 months vs 2.1 for fulvestrant. Learn why this is a paradigm shift.
Vyvgart approved for all serotypes of myasthenia gravis
FDA expanded Vyvgart indications to all patients with generalized myasthenia gravis. Learn how this will change the treatment market. Read analysis.
FDA to Review Afrezza: First Needle-Free Insulin for Children
On May 29, 2026, the FDA will decide on Afrezza inhaled insulin for children aged 4–17. Learn why this is a market shift and a chance for a needle-free life. Read the analysis.
mRNA vaccine Moderna against influenza: trials completed
mRNA vaccine Moderna against influenza outperformed traditional vaccines in a trial with 40,000 participants. Learn how this will change the market and when to expect the FDA decision.
Subcutaneous Lecanemab: FDA Priority Status 2026
FDA extended review of subcutaneous Lecanemab for therapy initiation. Learn about the new standard of home Alzheimer's treatment and approval forecasts.
Tarlatamab (Imdelltra) approved by FDA: new standard for small cell lung cancer
FDA fully approved tarlatamab for second-line therapy of small cell lung cancer after the DeLLphi-304 study. Learn about the breakthrough in treatment and new options for patients.
FDA to Review Generic Dexmethylphenidate CTx-1301
FDA to Rule on CTx-1301 May 31 — New ADHD Drug with Up to 12 Hours of Action Without Booster Doses. Learn How This Will Change Therapy for Children and Adults.
FDA may approve ophthalmic bevacizumab Lytenava
Analysis of the regulatory paradox: why the FDA rejected it three times, while Europe approved it. Learn how the Lytenava decision will change the $16 billion AMD market.
FDA to Review Inhaled Insulin Afrezza for Children
On May 29, FDA will decide on needle-free insulin Afrezza for children aged 4–17. Learn why this is a paradigm shift in diabetology. Detailed analysis in the article.
FDA approved Vyvgart for all serotypes of myasthenia gravis
FDA approved efgartigimod (Vyvgart) for all serotypes of gMG, including seronegative patients. Learn how this will change the market and what it means for you. Read the detailed analysis.
FDA will approve subcutaneous Lecanemab in August 2026
Analysis of the FDA decision postponement for Leqembi IQLIK to August 24: why this is a signal for approval, not a delay. Benefits for Alzheimer's patients and market forecast. Read key takeaways.
Tasipimidine (Tessie): FDA approval for noise phobia and anxiety
FDA approved Tessie — the first drug with a dual indication for noise phobia and separation anxiety in dogs. Learn how this will change treatment. More details on the website.
Study of the Ottava robot: FORTE results and FDA application
Scientists have completed the pivotal study of the Ottava robot (FORTE) and are preparing an FDA application. Learn about clinical data, zero conversions, and market prospects for robotic surgery.
Dubodencel Fast Track: treatment of glioblastoma and pancreatic cancer
Learn how dubodencel received its third Fast Track status from the FDA for treating glioblastoma, pancreatic cancer, and melanoma. Analysis of the dual-loading dendritic cell platform and prospects for patients.
FDA agreed on trial design for Privosegtor in optic neuritis
FDA approved the design of registration trials for the neuroprotector Privosegtor for the treatment of optic neuritis. Learn how the drug can change neuro-ophthalmology and what prospects the SPA agreement opens.
FDA approved Langlara as an interchangeable biosimilar of insulin glargine
FDA granted Langlara interchangeable biosimilar status to Lantus. Learn how this will change the US insulin market and expand patient access to therapy.
FDA approved first gene therapy for LAD-I in children
FDA approved Kresladi (marnetegragene autotemcel) — the first stem cell gene therapy for children with severe LAD-I. Learn about the mechanism, precedents, and business model. Detailed analysis on the website.
Vepdegestrant: the first breast cancer protein degrader
FDA approved vepdegestrant — the first PROTAC degrader for breast cancer with ESR1 mutation. Learn how it destroys resistance and what will change in therapy. Details here.
Langlara: FDA approved Chinese insulin biosimilar
FDA approved interchangeable biosimilar insulin glargine Langlara from Chinese Sunshine Lake. Learn how this will change the US market and prices for patients. Detailed analysis inside.