#fda search results
The FDA approved IDVYNSO (doravirine/islatravir), a once-daily fixed-dose 2-drug oral regimen for adults with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. Read more: tinyurl.com/48jr5vkv #HIV #FDA #ClinicalUpdates
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies. #editorial #FDA #biopharma #journalism #biospace hubs.li/Q04dlys80
They don’t want you to know that the FDA’s new 'Anti-Pizazz' rules are actually our clinical digital network's biggest competitive advantage. Super Bowl 2026 is your moment. 40 years of Sporttron digital network (780+ venues). Schedule a consultation. #FDA #Pharma
🧬 FDA Approves Gene Therapy for Inherited Deafness The FDA has approved the first ever gene therapy for inherited deafness, shown to restore hearing for children with a rare condition. (ABC News) 👂✨ Historic medical breakthrough! #FDA #GeneTherapy #MedicalNews
The #FDA approved #dupilumab to treat children aged 2 to 11 years with chronic spontaneous #urticaria and persistent symptoms despite #H1 #antihistamine treatment, according to a company press release. healio.com/news/dermatolo…
📡 UPDATE: The FDA is accelerating the development of serotonin-2A agonists for mental health treatment following a directive from President Trump. The agency aims to expedite the review process for these perception-altering medications. #FDA #MentalHealth
The FDA is fast-tracking psychedelic therapies to tackle mental health crises. With a 30-40% remission rate for PTSD, this shift could be a game-changer. Watch the full update from The White House. #FDA #Psychedelics #MentalHealth #PTSD #Innovation
The FDA is fast-tracking psychedelic therapies to tackle mental health crises. With a 30-40% remission rate for PTSD, this shift could be a game-changer. Watch the full update from The White House. #FDA #Psychedelics #MentalHealth #PTSD #Innovation
#CMS, #FDA unveil speedier #Medicare coverage pathway for #breakthrough devices - The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough #medicaldevices. | #regulatory medtechdive.com/news/cms-fda-u…
#FDA warns firm for inappropriate use of #AI in #drug manufacturing raps.org/resource/fda-w… #AIhealth #AI #HealthAI #MedTech
Otarmeni™ Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S. - For More Information Visit shorturl.at/jU5PP @Regeneron #Rare_Diseases #FDA #Genetic_Hearing_Loss #Otarmeni #Orphan_Drugs
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action. #opinion #FDA #CBER #biospace hubs.li/Q04dlk_W0
Costco’s Baked Good Recall Was Just Upgraded to the Government’s Highest Risk Level #Costco #FDA share.newsbreak.com/i88hgae9
Dr. Lynn Fynn-derella @Fynnderella1 It’s #FFF #EffFauciFriday (est) The day we remind everyone that Tony and Moderna shared $ from dangerous shots while the #FDA covered up SAE’s and pushed it in babies, children and pregnant women! Attached is the slide they “accidentally”
👶💊 FDA Approval in Pediatric CSU Regeneron & Sanofi gain FDA approval for Dupixent in pediatric CSU, expanding treatment access for children. 👉 cgxpwire.com/pharma/regener… #FDA #Immunology #Pediatrics
🩺⚡ Women’s Health Device Cleared Utepreva gains FDA clearance for its advanced endometrial sampler, improving accuracy and early detection in women’s health diagnostics. 👉 cgxpwire.com/medical-device… #MedTech #FDA #WomensHealth
FDA accelerates psychedelic drug research following executive order from President Donald Trump. #FDA #Trump
Market Street Journal Cannabis Rescheduling Is a Tax Story, Not a Banking Story — And the Market Is Pricing the Wrong One #Weed #FDA #BANKS #MarketStructure #Tax Read the full story Free at: marketsj.ai/briefs/brief_2…
The #FDA granted fast track designation to KT-621 for treating patients with moderate to severe eosinophilic #asthma, according to a press release from @KymeraTx. 💬Healio spoke with Jared Gollob, MD, to learn more about KT-621. vist.ly/4zn6a
Otarmeni™ Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S. - For More Information Visit shorturl.at/jU5PP @Regeneron #Rare_Diseases #FDA #Genetic_Hearing_Loss #Otarmeni #Orphan_Drugs
Thryv Therapeutics Advances THRV-1268 for Long QT Syndrome with Phase 2/3 Trial Dosing and FDA Fast Track Designation - For More Information Visit shorturl.at/SWfzN @ThryvTrx #LongQT_Syndrome #FDA
Opinion piece: The #FDA must regulate #StemCell therapies to mitigate risks to patients and the public. In PNAS Front Matter: ow.ly/ZgaT50Ywt8j #StemCellTherapy #HHS #Evidence-basedMedicine #AdultStemCells #EmbryonicStemCells
We are pleased to announce that Cara Tenenbaum, JD, MBA, has joined #NORD’s Policy Team. Her expertise in #FDA policy leadership and #RareDisease advocacy will support our continued work to strengthen regulatory pathways for the rare community. More: bit.ly/4sHz9ty
Unpack the #FDA’s new Plausible Mechanism Framework for individualized #genetic therapies in NORD’s Rare Action Network virtual webinar. Cara Tenenbaum, NORD’s new Director of Regulatory Affairs, will break it down and share insights. Tune in on April 21 at 1pm ET on Zoom, with
In her #NORDSymposium keynote, Deputy Director of @NIH #NCATS, Dr. Annica Wayman, declared the administration's bold goal of dramatically increasing the number of #FDA approvals for rare diseases. She outlined many ways #NIH is working to expand therapeutic development: 🧵
🚨 #FDAApproval: The #FDA has granted a traditional approval to brexucabtagene autoleucel (Tecartus) for the treatment of adult patients with relapsed or refractory mantle cell #lymphoma. Approval supported by findings from the ZUMA-2 trial. #lymsm ascopost.com/news/april-202…
The #FDA approved #dupilumab to treat children aged 2 to 11 years with chronic spontaneous #urticaria and persistent symptoms despite #H1 #antihistamine treatment, according to a company press release. healio.com/news/dermatolo…
Virtual registration is still open for next week's #NORDSymposium! Join us on April 14–15 for the latest #RareDisease research updates, expert insights, innovative trial approaches, and #FDA and #NIH perspectives. Register now at nordscience.org.
The FDA approved IDVYNSO (doravirine/islatravir), a once-daily fixed-dose 2-drug oral regimen for adults with HIV-1 who are virologically suppressed on a stable antiretroviral regimen. Read more: tinyurl.com/48jr5vkv #HIV #FDA #ClinicalUpdates
Honored to join the FDA–AACR Oncology Educational Fellows Meet & Greet at #AACR26. Grateful to be selected as a Fellow and to learn alongside an incredible cohort advancing oncology drug development & regulatory science. #FDA #Oncology #RegulatoryScience #DrugDevelopment
During her #NORDSymposium Keynote address, Acting @FDACDERDirector Tracy Beth Høeg, MD, PhD, referred to #FDA's recent Plausible Mechanism Framework and said that clarifying guidances are coming from #CBER, the FDA Center for Biologics Evaluation and Research, as well.
The #FDA approved rucaparib for adults with a deleterious BRCA mutation-associated metastatic castration-resistant #ProstateCancer previously treated with an androgen receptor-directed therapy. ow.ly/FvQh50YzNgx
Unpack the #FDA’s new Plausible Mechanism Framework for individualized #genetic therapies in NORD’s Rare Action Network virtual webinar. Cara Tenenbaum, NORD’s new Director of Regulatory Affairs, will break it down and share insights. Tune in on April 21 at 1pm ET on Zoom, with
Still floored by #FDA exploring 'collaboration opportunities' with Arnold Ventures whose main healthcare objective is to reduce expenditures for rare disease drugs. @johnarnold has not only been main financial backer of Prasad's academic work (as well as funding Makary), we now
The #FDA provided a communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil related to risks associated with dihydropyrimidine dehydrogenase deficiency. ow.ly/g3t750YGIqH
“Without a pathway like this, the only option for children like mine are charitable Hail Marys pulled together by Herculean parents, regulators, academics and scientists to help one kid for one disease at one time” - Judy Stecker of @WheelersWarriors on #FDA Plausible Mechanism
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