https://www.newswire.ca/news-releases/health-latest-news/fda-approval-list/
All FDA Approval News and Press Releases from Cision in Canada
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https://www.foxbusiness.com/video/6388378825112
Cytokinetics' heart drug hits market after FDA approval | Fox Business Video
Cytokinetics President and CEO Robert Blum discusses the state of cardiovascular care in America on 'Mornings with Maria.'
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https://www.everydayhealth.com/skin-conditions/ebglyss-new-biologic-treatment-for-eczema-fda-approval/
Ebglyss, a New Biologic Treatment for Atopic Dermatitis, Gets FDA Approval
Sep 17, 2024 - The new biologic Ebglyss (lebrikizumab-lbkz) requires a once-a-month self-administered injection.
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https://www.aol.com/articles/first-ever-gene-therapy-hearing-174721804.html
First-ever gene therapy for hearing loss gets FDA approval: 'Groundbreaking' - AOL
Apr 24, 2026 - The FDA has approved Otarmeni, the first-ever gene therapy for genetic hearing loss caused by the OTOF gene, for both pediatric and adult patients after...
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https://www.prnewswire.com/in/news-releases/health-latest-news/fda-approval-list/
All FDA Approval News and Press Releases from PR Newswire
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https://www.npr.org/transcripts/nx-s1-5795526
A gene therapy for a rare form deafness receives FDA approval : NPR
Apr 23, 2026 - The treatment, developed by Regeneron Pharmaceuticals, is for a very rare form of deafness. But it represents a medical milestone.
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https://www.aol.com/articles/first-ever-gene-therapy-hearing-174721932.html
First-ever gene therapy for hearing loss gets FDA approval: 'Groundbreaking' - AOL
Apr 24, 2026 - The FDA has approved Otarmeni, the first-ever gene therapy for genetic hearing loss caused by the OTOF gene, for both pediatric and adult patients after...
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https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia
LENZ Therapeutics Announces US FDA Approval of VIZZ™ for the Treatment of Presbyopia :: LENZ...
VIZZ is the first and only aceclidine-based eye drop approved to improve near vision in adults with presbyopia, a condition impacting…...
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https://www.wired.com/story/paradromics-gets-fda-approval-to-trial-its-brain-implant-in-people/
Paradromics Gets FDA Approval to Trial Its Brain Implant in People | WIRED
Nov 20, 2025 - The Austin-based startup will test its high-bandwidth device to help restore speech in people with extremely limited movement.
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https://www.everydayhealth.com/obesity/fda-approves-new-type-of-glp-1-pill-for-weight-loss/
New GLP-1 Pill Foundayo (Orforglipron) Gets FDA Approval for Obesity
Apr 1, 2026 - This innovative oral GLP-1 is a ‘small molecule’ medication that, unlike the Wegovy pill, doesn’t require that you take it on an empty stomach.
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https://www.everydayhealth.com/diabetes/once-a-week-insulin-shot-is-a-game-changer-for-type-2-diabetes/
Awiqli, a Once-a-Week Insulin Shot for Type 2 Diabetes, Gets FDA Approval
Mar 27, 2026 - Some patients with type 2 diabetes will be able to switch from daily insulin injections to this first-of-its-kind once-weekly alternative.
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https://www.prnewswire.com/news-releases/policy-public-interest-latest-news/fda-approval-list/
All FDA Approval News and Press Releases from PR Newswire
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https://www.prweb.com/releases/policy-public-interest-latest-news/fda-approval-list/
All FDA Approval News and Press Releases from PRWeb
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https://www.buzzfeednews.com/article/juliareinstein/federal-judge-mifepristone-abortion-drug-ruling
Federal Judge Suspends FDA Approval Of Abortion Pill Mifepristone
Apr 10, 2023 - It wasn’t immediately clear what the dueling opinions will mean for access to medication abortion. The conflict “almost guarantees that the Supreme Court will...
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https://www.npr.org/2026/04/23/nx-s1-5795526/deafness-gene-therapy-regeneron
A gene therapy for a rare form deafness receives FDA approval : NPR
Apr 23, 2026 - The treatment, developed by Regeneron Pharmaceuticals, is for a very rare form of deafness. But it represents a medical milestone.
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https://apnews.com/article/mdma-fda-psychedelic-therapy-ptsd-treatment-drug-bc2d7495035a9532876c3dcaf52a9761
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD | AP News
May 31, 2024 - Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD.
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https://www.scientificamerican.com/article/a-psychedelic-may-soon-go-to-the-fda-for-approval-to-treat-trauma/
A Psychedelic May Soon Go to the FDA for Approval to Treat Trauma | Scientific American
Feb 20, 2024 - MDMA, known as Ecstasy in the clubs, gained high marks in a clinical trial for PTSD
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https://reports.statnews.com/collections/all-reports/products/speed-and-safety-fdas-drug-approval
A guide to the FDA's drug approval pathways and processes | STAT Reports
Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency...
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https://www.statnews.com/2026/03/03/prime-medicine-seeks-fda-approval-cgd-disease-gene-editing-treatment/
Prime Medicine seeks FDA treatment approval after two-patient trial | STAT
Mar 4, 2026 - Prime Medicine's application will test an FDA that has promised to speed new gene-editing treatments but has recently spurned some.
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https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/
How Biogen used an FDA back channel to win Alzheimer's drug approval
Jul 31, 2023 - When Aduhelm’s prospects appeared dead, Biogen mounted a secret campaign to resurrect the drug and convince the FDA to approve it.
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https://www.sun-sentinel.com/2026/04/01/eli-lilly-weight-loss-pill/
FDA grants speedy approval to Eli Lilly's weight-loss pill for obesity
Apr 1, 2026 - U.S. health officials have approved a new weight-loss pill from Eli Lilly. The Food and Drug Administration
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https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications
Oncology (Cancer)/Hematologic Malignancies Approval Notifications | FDA
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the...
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https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
FDA and Cannabis: Research and Drug Approval Process | FDA
Information about FDA and cannabis
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https://www.scientificamerican.com/article/rfk-jr-puts-psychedelics-on-fast-track-to-fda-review-and-approval/
RFK, Jr., puts psychedelics on fast track to FDA review and approval | Scientific American
Apr 24, 2026 - The U.S. Food and Drug Administration is seeking to accelerate the review process for three companies that are studying psilocybin and an MDMA-like drug as...
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https://www.npr.org/2026/02/23/nx-s1-5720948/fda-rare-disease-gene-therapy
FDA says a plausible mechanism can be enough for rare disease approval : NPR
Feb 23, 2026 - The Food and Drug Administration aims to evaluate treatments for rare diseases based on plausible evidence that they would work — without requiring a clinical...
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https://apnews.com/article/fda-drugs-makary-trump-accelerated-approval-752146d97521b1644c9b10f2c6361f33
Marty Makary, Trump's FDA commissioner, announces faster drug approval program | AP News
Jun 17, 2025 - The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans'...
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https://www.fda.gov/animal-veterinary/resources-you/conditional-approval-explained-resource-veterinarians
Conditional Approval Explained: A Resource for Veterinarians | FDA
Conditional approval differs from full approval in several ways, and these key differences have implications for veterinarians who use conditionally-approved...
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https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber
Development & Approval Process (CBER) | FDA
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https://www.fda.gov/drugs/development-approval-process-drugs
Development & Approval Process | Drugs | FDA
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
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https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-carvykti-ciltacabtagene-autoleucel-treatment-adult-patients
FDA D.I.S.C.O. Burst Edition: FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the...
Listen to a soundcast of the 2/28/2022 FDA approval of CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple...
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