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!
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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