Robuta

https://microsmallcap.com/health/biotechnology/fda-approves-bayers-nubeqa-for-wider-use-in-prostate-cancer-subtype/ FDA Approves Bayer’s Nubeqa for Wider Use in Prostate Cancer Subtype. Aug 9, 2022 - In combination with docetaxel, the U.S. Food and Drug Administration (FDA) has approved Bayer's Nubeqa for the treatment of hormone-sensitive metastatic fda approvesprostate cancerwiderusesubtype https://lymphoma.org/news/the-u-s-food-and-drug-administration-fda-approves-nivolumab-for-hodgkin-lymphoma/ The U.S. Food and Drug Administration (FDA) Approves Nivolumab for Hodgkin Lymphoma | Lymphoma... Mar 20, 2026 - The U.S. Food and Drug Administration (FDA) Approves Nivolumab for Hodgkin Lymphoma March 20, 2026- On March 20, 2026, the U.S. Food and Drug drug administrationfda approvesfoodhodgkinlymphoma https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease | FDA The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older. One of... fda approvesgene therapiessickle cellfirsttreat https://www.pharmaadvancement.com/pharma-news/u-s-fda-approves-weight-loss-pill-from-novo-nordisk/ U.S. FDA Approves Weight Loss Pill from Novo Nordisk Dec 30, 2025 - FDA approval of the Weight Loss Pill from Novo Nordisk marks a milestone for oral obesity treatment, expanding access and strengthening current market position fda approvesweight losspillnovonordisk https://www.foxbusiness.com/lifestyle/fda-approves-fruit-flavored-vapes-first-time-after-reported-trump-pressure FDA approves fruit-flavored e-cigarettes for the first time in US history | Fox Business May 5, 2026 - The FDA authorized fruit-flavored e-cigarettes for the first time, approving mango, blueberry and menthol pods by Los Angeles-based Glas Inc., which uses... fda approvesfruit flavoredfirst timeus historycigarettes https://www.fda.gov/news-events/press-announcements/fda-approves-new-safety-warning-and-revised-indication-limits-use-elevidys-following-reports-fatal FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following... The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a... fda approvesnew safetywarningrevisedindication https://www.fda.gov/news-events/press-announcements/fda-approves-first-ever-gene-therapy-treatment-genetic-hearing-loss-under-national-priority-voucher FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority... The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene... fda approvesfirst evergene therapyhearing losstreatment https://www.uspharmacist.com/topic/lung-cancer FDA Approves Rybrevant Faspro for EGFR-Mutated NSCLC fda approvesegfrnsclc https://www.biopharmadive.com/news/krystal-fda-approval-gene-therapy-epidermolysis-bullosa/650844/ FDA approves Krystal gene therapy for rare wound disorder | BioPharma Dive Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S. fda approvesgene therapykrystalrarewound https://www.nccc-online.org/fda-approves-at-home-collection-device-for-hpv-testing-cervical-cancer-screening/ FDA Approves At-Home Collection Device for Cervical Cancer Screening – NCCC cervical cancer screeningfda approvescollectiondevicenccc https://www.nsmedicaldevices.com/news/fda-approves-investigational-device-exemption-for-early-feasibility-study-for-rehabilitation-of-stroke-patients-using-cortecs-closed-loop-brain-interchangeimplant-system/ FDA approves Investigational Device Exemption for Early Feasibility Study for rehabilitation of... Jun 17, 2025 - CorTec has announced today that the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application by the University... fda approvesfeasibility studyinvestigationaldeviceexemption https://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa FDA Approves First Topical Gene Therapy for Treatment of Wounds in Patients with Dystrophic... FDA approves Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with... fda approvesgene therapyfirsttopicaltreatment https://lifeboat.com/blog/2026/05/fda-approves-novel-weekly-basal-insulin-for-t2d FDA Approves Novel Weekly Basal Insulin for T2D – Lifeboat News: The Blog The FDA has approved once-weekly insulin icodec-abae (Awiqli; Novo Nordisk) for use in adults with type 2 diabetes (T2D), with a current projected launch in... fda approveslifeboat newsnovelweeklybasal https://www.selectscience.net/article/agilent-receives-fda-approval-for-pd-l1-ihc-22c3-pharmdx-in-esophageal-and-gej-carcinoma FDA approves Agilent PD-L1 test for esophageal cancer - SelectScience news Agilent’s PD-L1 IHC 22C3 pharmDx wins expanded FDA approval to guide KEYTRUDA use in esophageal and GEJ cancer patients. Read expert insights on SelectScience. fda approvesesophageal canceragilentpdtest https://www.mymatrixx.com/news/fda-approves-first-semaglutide-pill-weight-loss FDA approves first semaglutide pill for weight loss Jan 12, 2026 - On December 22, 2025, Novo Nordisk announced the FDA's approval of the first oral GLP-1 receptor agonist semaglutide. The drug is approved to lower weight and... fda approvesfirstsemaglutidepillweight https://www.medtechdive.com/news/fda-approves-one-year-contraceptive-ring/530023/ FDA approves one-year contraceptive ring | MedTech Dive The product, developed by the nonprofit Population Council, will be made available in the U.S. through a license agreement with women's health company... fda approvesone yearcontraceptiveringmedtech https://dawningpr.com/fda-approves-new-gene-therapy-treatment-for-kids-priced-at-4-25-million/ FDA approves new gene therapy treatment for kids priced at $4.25 million - Dawning PR Aug 27, 2025 - Kendra Riley is a mother of three girls, two of whom — Olivia and Keira — were diagnosed with MLD. While Keira was fortunate to receive the gene therapy in... fda approvesgene therapynewtreatmentkids https://www.novopept.com/news/fda-approves-novo-nordisk-s-oral-weight-loss-p-85361114.html FDA Approves Novo Nordisk’s Oral Weight-Loss Pill — What This Means For Consumers And The Future Of... Dec 23, 2025 - FDA Approves Novo Nordisk’s Oral Weight-Loss Pill — What This Means For Consumers And The Future Of Oral GLP-1 Medications fda approvesweight lossnovooralpill https://www.biopharmadive.com/news/gilead-fda-approves-yeztugo-lenacapavir-hiv-prep/750742/ FDA approves twice-yearly shot of Gilead drug for HIV prevention | BioPharma Dive The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines. fda approveshiv preventiontwiceyearlyshot https://www.fooddive.com/news/fda-approves-natural-colors-artificial-dye-phase-out-food/747964/ FDA approves 3 natural colors to accelerate food industry transition from artificial dyes | Food... The move expands the color palette for companies as they face calls to end use of synthetic additives before the end of 2026. fda approvesnatural colorsfood industryacceleratetransition https://aasm.org/fda-approves-wakix-for-cataplexy-in-pediatric-narcolepsy/ FDA approves Wakix for cataplexy in pediatric narcolepsy Feb 24, 2026 - The FDA approved Wakix (pitolisant) to treat cataplexy in children ages 6 and older with narcolepsy, expanding its pediatric indication. fda approvespediatricnarcolepsy https://www.bigmoleculewatch.com/2026/04/14/fda-approves-extended-dosing-interval-for-regenerons-eylea-hd-aflibercept/ FDA Approves Extended Dosing Interval for Regeneron's EYLEA HD (aflibercept) - Big Molecule Watch On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD... fda approvesbig moleculeextendeddosinginterval https://www.medtechdive.com/news/fda-approves-2-devices-to-aid-in-thyroid-surgery/541375/ FDA approves 2 devices to aid in thyroid surgery | MedTech Dive The products sold by Fluoptics and AiBiomed are designed to help surgeons locate parathyroid tissue or glands, which can be difficult to see during a procedure. fda approvesdevicesaidthyroidsurgery https://www.biopharmadive.com/news/covid-booster-fda-approval-limits-kennedy-pfizer-moderna/758183/ FDA approves updated COVID boosters, but narrows use | BioPharma Dive Aug 27, 2025 - While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in younger people to those with... fda approvesupdated covidboostersnarrowsuse https://www.medtechdive.com/news/fda-approves-cochlear-implant-designed-for-mri/557089/ FDA approves cochlear implant designed for MRI | MedTech Dive The implant is designed for safe access to magnetic resonance imaging scans and doesn't require a head wrap or removal of the device's internal magnet. fda approvescochlear implantdesignedmrimedtech https://www.mymatrixx.com/news/fda-approves-foundayotm-chronic-weight-management FDA approves Foundayo™ for Chronic Weight Management Apr 8, 2026 - On April 1, 2026, the FDA approved Eli Lilly and Company's FoundayoTM - a treatment for chronic weight management. The once-daily, oral medication is available... fda approveschronicweightmanagement https://piano-wombat-gb7p.squarespace.com/latest/fda-approves-the-first-ever-over-the-counter-birth-control-pill-in-the-united-states FDA Approves The First-Ever Over-The-Counter Birth Control pill In The United States — Free The Pill Jul 13, 2023 - The US Food and Drug Administration has approved Opill, a progestin-only birth control pill (POP), for over-the-counter (OTC) use! fda approvesfirst everbirth controlunited statescounter https://www.medicalnewstoday.com/articles/fda-approves-oral-glp-1-pill-foundayo-for-weight-loss FDA approves Foundayo, an oral GLP-1 alternative to Wegovy Apr 8, 2026 - Under the new priority voucher program (CNPV), the FDA has approved a new oral GLP-1 drug, Foundayo, offering an alternative to Wegovy and injectable GLP-1s... fda approvesfoundayooralglpalternative https://mdaquest.org/fda-approves-sanofi-genzymes-nexviazyme-for-treatment-of-pompe-disease/ FDA Approves Sanofi Genzyme’s Nexviazyme for Treatment of Pompe Disease - Quest | Muscular... May 19, 2022 - Quest strives to empower, inform, and engage with updates on research and clinical trials, conversations with thought leaders, and stories that explore... fda approvessanofitreatmentpompedisease https://www.indiapharmaoutlook.com/news/fda-approves-roch-s-nsclc-diagnostic-linked-to-emrelis-nwid-3500.html FDA Approves Roch's NSCLC Diagnostic Linked to Emrelis Roche has announced FDA approval for the Ventana MET (SP44) RxDx Assay, emphasizing their first companion diagnostic designed to identify MET protein... fda approvesrochnsclcdiagnosticlinked https://www.ashasexualhealth.org/fda-approves-a-new-at-home-test-for-three-common-stis/ FDA Approves A New At-Home Test For Three Common STIs | American Sexual Health Association Nov 17, 2025 - The FDA just approved a new, fully at-home test for chlamydia, gonorrhea, and trichomoniasis. The tests, which is only for women, will be available without a... american sexual healthfda approvesnewtestthree https://www.medtechdive.com/news/fda-approves-keytruda-companion-test-for-bladder-cancer/530648/ FDA approves Keytruda companion test for bladder cancer | MedTech Dive Measuring levels of PD-L1 expressed in patients' tumors can help doctors determine who is likely to benefit from immunotherapy treatment. fda approvesbladder cancerkeytrudacompaniontest https://www.biopharmadive.com/news/covid-booster-fda-approval-pfizer-moderna-xbb-omicron/693311/ FDA approves updated COVID boosters from Pfizer, Moderna | BioPharma Dive Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect their reformulated shots will soon be available in the U.S. fda approvesupdated covidboosterspfizermoderna https://www.kitepharma.com/news/press-releases/2026/2/fda-approves-label-update-for-kites-yescarta-for-relapsedrefractory-primary-central-nervous-system-lymphoma FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous... FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma fda approveslabelupdaterelapsedrefractory https://www.thermalpr.com/news/fda-approves-worlds-first-crispr-gene-editing-drug-for-sickle-cell-disease/ FDA Approves World’s First Crispr Gene-Editing Drug for Sickle-Cell Disease Jul 18, 2024 - Here you can read our article about FDA Approves World’s First Crispr Gene-Editing Drug for Sickle-Cell Disease . crispr gene editingfda approvessickle cellfirstdrug https://www.ddw-online.com/fda-approves-first-gene-therapy-for-genetic-hearing-loss-41397-202604/ FDA approves first gene therapy for genetic hearing loss - Drug Discovery World (DDW) fda approvesgene therapyhearing lossdrug discoveryfirst https://www.lupus.org/news/fda-approves-saphnelo-selfadministration-for-treatment-of-systemic-lupus-erythematosus FDA Approves SAPHNELO Self-Administration for Treatment of Systemic Lupus Erythematosus | Lupus... fda approvesselfadministrationtreatmentsystemic https://www.kristv.com/news/national-news/fda-approves-first-fruit-flavored-e-cigarettes-for-adult-smokers FDA approves first fruit-flavored e-cigarettes for adult smokers May 6, 2026 - The newly authorized e-cigarettes come in mango, blueberry and two varieties of menthol. fda approvesfruit flavoredfirstcigarettesadult https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-serious-liver-disease-known-mash FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’ | FDA Action Will Provide New Therapy for Growing Public Health Issue fda approvesliver diseasetreatmentseriousknown https://www.wfft.com/news/fda-approves-first-gene-therapy-for-inherited-deafness-shown-to-restore-hearing-for-children-with/article_79dad1f5-b82f-5e99-a523-e4c43ffc0c57.html FDA approves first gene therapy for inherited deafness, shown to restore hearing for children with... (CNN) — The US Food and Drug Administration on Thursday approved the first gene therapy for inherited hearing loss, a one-time treatment that proved to be... fda approvesgene therapyfirstinheriteddeafness https://www.biopharmadive.com/news/pfizer-rsv-vaccine-maternal-fda-approval/691072/ FDA approves Pfizer’s RSV vaccine for use in pregnancy | BioPharma Dive The shot, called Abrysvo, is the first maternal immunization approved to protect newborns from the respiratory virus in their first months of life. fda approvesrsv vaccineusepregnancybiopharma https://mdaquest.org/fda-approves-avexis-zolgensma-for-treatment-of-spinal-muscular-atrophy-in-pediatric-patients/ FDA Approves AveXis’ Zolgensma for Treatment of Spinal Muscular Atrophy in Pediatric Patients -... Oct 9, 2024 - Quest strives to empower, inform, and engage with updates on research and clinical trials, conversations with thought leaders, and stories that explore... spinal muscular atrophyfda approvestreatmentpediatricpatients https://babylonbee.com/news/fda-approves-just-faith-treatment-clinical-depression-christians FDA Approves 'Just Have More Faith' Treatment For Clinical Depression In Christians | Babylon Bee SILVER SPRING, MD—The Food and Drug Administration has approved a promising new treatment for severe depression and crippling anxiety in Christians, consisting... fda approvesfaithtreatmentclinicaldepression https://netchoice.org/ais-transformative-power-fda-approves-first-ever-ai-system-to-help-identify-sepsis-early/ AI’s Transformative Power: FDA Approves First Ever AI System to Help Identify Sepsis Early -... Relentless innovation in artificial intelligence (AI) tools continues to transform the world for the better – and that is certainly the case in healthcare.... transformative powerfda approvesfirst everai systemhelp https://apnews.com/article/wegovy-weight-loss-high-dose-novo-nordisk-02eda78523db91e2dc4810e955291481 FDA approves high-dose Wegovy shots | AP News Mar 19, 2026 - U.S. regulators on Thursday approved a new higher-dose version of the blockbuster obesity drug Wegovy. fda approveshigh dosewegovyshotsnews https://mdaquest.org/fda-approves-sarepta-therapeutics-vyondys-53-for-treatment-of-dmd-amenable-to-exon-53-skipping/ FDA Approves Sarepta Therapeutics’ Vyondys 53 for Treatment of DMD Amenable to Exon 53 Skipping -... Jun 23, 2025 - Quest strives to empower, inform, and engage with updates on research and clinical trials, conversations with thought leaders, and stories that explore... fda approvessareptatreatmentdmdamenable https://www.medtechdive.com/news/fda-approves-medtronic-implant-for-rare-form-of-hypertension/529042/ FDA approves Medtronic implant for rare form of hypertension | MedTech Dive United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin. fda approvesmedtronicimplantrareform https://nephcure.org/fda-approves-sparsentan-for-fsgs-marking-a-landmark-achievement-for-patients-living-with-rare-kidney-disease/ FDA Approves Sparsentan for FSGS, Marking a Landmark Achievement for Patients Living with Rare... Apr 14, 2026 - Brian Kennedy joins NephCure's Board of Directors, bringing his advocacy and achievements to the fight against rare kidney diseases. fda approvesmarkinglandmarkachievementpatients https://www.joemygod.com/2026/05/fda-approves-flavored-vapes-after-trump-pressure/ FDA Approves Flavored Vapes After Trump Pressure - Joe.My.God. May 6, 2026 - The Washington Post reports: The Food and Drug Administration on Tuesday authorized the first fruit-flavored vapes for adults 21 and over amid President Donald... fda approvesflavoredvapestrumppressure https://www.medtechdive.com/news/fda-approves-first-of-its-kind-heart-failure-device/551090/ FDA approves first-of-its-kind heart failure device | MedTech Dive The implantable system from Impulse Dynamics is indicated for patients with Class III moderate to severe heart failure who are not eligible for cardiac... fda approveskind heartfirstfailuredevice https://www.thermalpr.com/news/fda-approves-first-gene-editing-treatment-for-human-illness/ FDA approves first gene-editing treatment for human illness Dec 14, 2023 - Here you can read our article about FDA approves first gene-editing treatment for human illness . fda approvesgene editingfirsttreatmenthuman https://www.pharmafocusamerica.com/news/fda-approves-pfizer-and-arvinas-oral-protac-degrader-for-breast-cancer-subtype FDA Approves Pfizer and Arvinas' Oral PROTAC Degrader for Breast Cancer Subtype The FDA has granted approval to Pfizer and Arvinas' groundbreaking oral PROTAC degrader, marking a significant advancement in targeted therapies for a specific... fda approvesprotac degraderbreast cancerpfizeroral https://freethepill.org/latest/fda-approves-the-first-ever-over-the-counter-birth-control-pill-in-the-united-states FDA Approves The First-Ever Over-The-Counter Birth Control pill In The United States — Free The Pill Jul 13, 2023 - The US Food and Drug Administration has approved Opill, a progestin-only birth control pill (POP), for over-the-counter (OTC) use! fda approvesfirst everbirth controlunited statescounter https://www.biopharmadive.com/news/gsk-blujepa-fda-approval-uti-antibiotic/743590/ FDA approves first-of-its-kind antibiotic from GSK | BioPharma Dive The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise. fda approvesfirstkindantibioticgsk https://www.biopharmadive.com/news/entasis-fda-approval-xacduro-bacterial-pneumonia/651112/ FDA approves new antibiotic for hospital-acquired pneumonia | BioPharma Dive The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis... fda approvesnewantibiotichospitalacquired https://www.nature.com/articles/d41573-025-00082-2?error=cookies_not_supported&code=26939255-d0e8-43a4-ac6b-8020e16a736e FDA approves cell-sheet-based gene therapy for severe skin disease May 28, 2025 - Discover the world’s best science and medicine | Nature.com fda approvesgene therapycellsheetbased https://www.highereddive.com/news/colleges-add-vaccine-mandates-after-fda-fully-approves-pfizer-shots/605523/ Colleges add vaccine mandates after FDA fully approves Pfizer shots | Higher Ed Dive Several schools announced new requirements, while others implemented plans that had been waiting on one of the vaccines in the U.S. gaining approval. vaccine mandateshigher edcollegesaddfda