Live and recent posts from across the Fediverse tagged #drugapproval, aggregated by home.social.
Drug Trial Data Manipulation Wiped Avacopan’s EU Approval as FDA Hearing Looms
When regulators at the European Medicines Agency published the full scientific rationale behind Europe’s withdrawal of avacopan on…
#Europe #EU #EuropeanCommission #ADVOCATEtrialdatamanipulation #Amgen #avacopanFDAwithdrawal #clinicaltrial #drugapproval #EMA #FDA #TavneosEUrevocation
https://www.europesays.com/europe/116040/
FDA approves Reckitt’s new Mucinex cold, flu medicine
Reckitt has received approval from the U.S. Food and Drug Administration for a long-lasting cold and flu symptom-relief…
#EuropeSays #Britain #Europe #EU #ReckittBenckiser #coldandflu #consumerhealth #drugapproval #FDA #Mucinex #NewDrugApplication #Nutley #over-the-countermedication #Pharmaceuticals #Reckitt
https://www.europesays.com/britain/99301/
https://www.europesays.com/britain/99301/ FDA approves Reckitt’s new Mucinex cold, flu medicine #ColdAndFlu #ConsumerHealth #DrugApproval #FDA #Mucinex #NewDrugApplication #Nutley #OverTheCounterMedication #Pharmaceuticals #Reckitt #ReckittBenckiser
Cetirizine Recall: Check These Generic Zyrtec Lot Numbers Nationwide
Take allergy medicine? Check your medicine cabinets. Four lots of the widely used allergy medication are being recalled…
#NewsBeep #News #Healthcare #Allergies #AU #Australia #drugapproval #FDA #Health #prescriptionrecall
https://www.newsbeep.com/au/826957/
https://www.europesays.com/ie/606432/ Cetirizine Recall: Check These Generic Zyrtec Lot Numbers Nationwide #allergies #DrugApproval #Éire #fda #Health #HealthCare #Healthcare #IE #Ireland #PrescriptionRecall
https://www.europesays.com/africa/332013/ Sun Pharma shares gain after South Africa approval for generic semaglutide #DrugApproval #GenericDrug #pharmaceutical #SAHPRA #semaglutide #SouthAfrica #SunPharma #SunPharmaSemaglutideSouthAfrica #Type2Diabetes
AstraZeneca shares slide after Ionis-partnered drug fails late-stage heart disease trial
AstraZeneca shares tumbled on Thursday after the company said its nerve disease drug Wainua, made in partnership with…
#EuropeSays #Britain #Europe #EU #AstraZeneca #biopharmaceuticals #cardiovasculardeaths #ClinicalTrialResults #drugapproval #Heartdisease #IonisPharmaceuticals #late-stagetrial #transthyretin-mediatedamyloidcardiomyopathy #Wainua
https://www.europesays.com/britain/79678/
https://www.europesays.com/britain/79678/ AstraZeneca shares slide after Ionis-partnered drug fails late-stage heart disease trial #AstraZeneca #biopharmaceuticals #CardiovascularDeaths #ClinicalTrialResults #DrugApproval #HeartDisease #IonisPharmaceuticals #LateStageTrial #TransthyretinMediatedAmyloidCardiomyopathy #Wainua
Psychedelics: A Rush Towards Regulatory Acceptance
Government is making it faster to approve new psychedelic drugs for depression, PTSD, and addiction. Find out how this helps patients.
#PsychedelicTherapy, #MentalHealth, #DrugApproval, #FDA, #NewTreatments
https://newsletter.tf/psychedelic-drug-rules-speed-approval-mental-health/
New rules mean psychedelic drugs for mental health could reach patients years sooner than expected. This is a big change from old rules.
#PsychedelicTherapy, #MentalHealth, #DrugApproval, #FDA, #NewTreatments
https://newsletter.tf/psychedelic-drug-rules-speed-approval-mental-health/
Institutional Mismatch: The Fragility of Biotech Governance
FDA leadership changes cause delays and confusion for new biotech drug approvals. Scientists and investors are affected by the lack of clear rules.
#FDADelays, #BiotechNews, #DrugApproval, #USPolitics, #HealthcareUpdate
https://newsletter.tf/fda-leadership-loss-biotech-drug-approvals-2026/
New FDA rules are causing confusion for biotech companies. This is different from last year when approvals were faster.
#FDADelays, #BiotechNews, #DrugApproval, #USPolitics, #HealthcareUpdate
https://newsletter.tf/fda-leadership-loss-biotech-drug-approvals-2026/
X4 Pharmaceuticals Announces European Commission Approval
– European Commercialization will be Led by X4 Pharmaceuticals’ Partner, Norgine – – Global, Pivotal Phase 3 Clinical…
#Europe #EU #drugapproval #European #Hematology #Nasdaq:XFOR #X4Pharmaceuticals
https://www.europesays.com/europe/26220/
X4 Pharmaceuticals Announces European Commission Approval
– European Commercialization will be Led by X4 Pharmaceuticals’ Partner, Norgine – – Global, Pivotal Phase 3 Clinical…
#Europe #EU #drugapproval #European #Hematology #Nasdaq:XFOR #X4Pharmaceuticals
https://www.europesays.com/europe/26109/
Crinetics wins EU approval for acromegaly drug Palsonify
Crinetics Pharmaceuticals (NASDAQ: CRNX) announced European Commission approval of PALSONIFY (paltusotine) for treatment…
#Europe #EU #EuropeanCommission #acromegaly #CrineticsPharmaceuticals #CRNX #drugapproval #EuropeanCommissionapproval #Palsonify #paltusotine #raredisease
https://www.europesays.com/europe/24538/
https://www.europesays.com/dk/54227/ New Foundayo weight loss pill approved by FDA. Here’s what it costs and how it compares to Zepbound #DrugApproval #DummyPill #EliLilly #FDA #NovoNordisk #OralMedication #orforglipron #WeightLoss
Why drug approval in Canada should not rely on foreign regulators
#Canada #Health #DrugApproval #PharmaIndustry #PublicHealth #FDA #EMA #HealthcarePolicy #PatientSafety #MedicalEthics #Regulation #BigPharma #HealthPolicy #Politics #EvidenceBasedMedicine
https://the-14.com/why-drug-approval-in-canada-should-not-rely-on-foreign-regulators/
FDA rejects Vanda’s jet lag drug following yearslong dispute and 'long-shot' review – Endpoints News
FDA rejects Vanda’s jet lag drug following yearslong dispute and ‘long-shot’ review Endpoints NewsFDA rejects Vanda’s jet lag treatment…
#NewsBeep #News #Medication #CA #Canada #circadianrhythm #clinicaltrials #Drugapproval #FDA #Health #HETLIOZ #jetlagdisorder #Non-24-hoursleep-wakedisorder #Pharma #sleepdisorders #Smith-Magenissyndrome #VandaPharmaceuticals
https://www.newsbeep.com/ca/405309/
DATE: December 19, 2025 at 04:31PM
SOURCE: BioWorld MedTech
Direct article link at end of text block below.
RT @BioWorld: Rare diseases drive November’s US drug approvals https://t.co/SGKYslzA1X #biopharma @US_FDA #RareDisease #DrugApproval @Arrow…
Here are any URLs found in the article text:
Articles can be found by scrolling down the page at https://www.bioworld.com/topics/85-bioworld-medtech .
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Thuốc chữa ung thư Pembroria do Nga sản xuất đã được Bộ Y tế cấp phép lưu hành tại Việt Nam theo đúng quy định. Cục Quản lý Dược khẳng định thuốc đã hoàn thành thử nghiệm lâm sàng và đang được nhập khẩu, sử dụng rộng rãi, mang lại thêm lựa chọn điều trị cho người bệnh ung thư trong nước.
#Pembroria #ThuốcUngThư #Nga #BộYTế #ĐiềuTrịUngThư #Health #CancerTreatment #Vietnam #MedicalNews #UngThư #Dược #YTe #DrugApproval #ClinicalTrial
https://vietnamnet.vn/bo-y-te-thuoc-chua-ung-thu-cua-nga-duoc-n
🇻🇳 Thuốc ung thư Pembroria do Nga sản xuất đã được Cục Quản lý Dược (Bộ Y tế) cấp giấy đăng ký lưu hành tại Việt Nam, với hơn 14 chỉ định cho các loại ung thư khác nhau. #yte #sứckhỏe #ungthu #cancertreatment #Vietnam #Russia #drugapproval #pharmaceutic
https://vietnamnet.vn/thuoc-ung-thu-do-nga-san-xuat-duoc-luu-hanh-tai-viet-nam-2461724.html
Rankin County teen wins battle for treatment with FDA drug approval
RANKIN CO., Miss. (WLBT) – The U.S. Food and Drug Administration’s denial of a life-changing medication pushed a…
#NewsBeep #News #Medication #AU #Australia #BarthSyndrome #battle #christopherpena #D.C. #disease #drugapproval #elamipretide #FDA #foodanddrugadministration #Forzinty #Health #medicine #rankincounty #rankincountyteen #treatment #washington
https://www.newsbeep.com/au/170768/
Gizmodo: FDA’s New Drug Approval AI Is Generating Fake Studies: Report. “CNN spoke with six current and former employees at the FDA, three of whom have used Elsa for work that they described as helpful, like creating meeting notes and summaries. But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI as ‘hallucinating.’ The […]
FDA: FDA Embraces Radical Transparency by Publishing Complete Response Letters. “The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the […]
Revolutionizing Drug Approval: The Case for Privatizing the FDA
As the FDA's monopoly on drug approvals stifles innovation and delays access to life-saving treatments, a radical proposal emerges: privatizing the drug approval process. By establishing Drug Certific...
https://news.lavx.hu/article/revolutionizing-drug-approval-the-case-for-privatizing-the-fda
SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing - Enlarge / Demonstrators participate in an abortion-rights rally outside... - https://arstechnica.com/?p=2012710 #ketanjibrownjackson #medicationabortion #clarencethomas #drugapproval #mifepristone #abortion #comstock #science #barrett #gorsuch #policy #scotus #alito #kagan #fda
Health Canada should be transparent about how it’s monitoring drug safety
#Canada #Health #HealthCanada #Pharmaceuticals #BigPharma #Drugs #DrugSafety #ClinicalTrials #DrugApproval #PharmaCompanies #Pharma
https://the-14.com/health-canada-should-be-transparent-about-how-its-monitoring-drug-safety/
Canada should review how deferiprone was approved, doctors say | The Star https://bit.ly/3ojRBMU #HealthCanada #DrugApproval #deferiprone #UHN #DrugTrials #cdnpoli @canadiangreens @cdnpoli
Amid firestorm of criticism, FDA narrows use of $56,000 Alzheimer’s drug - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1779094 #drugapproval #alzheimers #science #aduhelm #biogen #fda
Controversial Alzheimer’s drug could cost US $334B—nearly half of DoD budget - Enlarge / Pedestrians walk past Biogen Inc. headquarters in Cambridge, Massachuse... - https://arstechnica.com/?p=1776882 #drugapproval #alzheimers #medicare #science #biogen #fda
FDA officials asked to step down after contentious Alzheimer’s drug approval - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1774338 #alzheimersdrug #publiccitizen #drugapproval #aducanumab #science #aduhelm #biogen #fda
Three experts resign as FDA advisors over approval of Alzheimer’s drug - Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (... - https://arstechnica.com/?p=1772629 #alzheimersdisease #drugapproval #science #biogen #fda
A “disgraceful decision:” Researchers blast FDA for approving Alzheimer’s drug - Enlarge (credit: Getty | Congressional Quarterly)
The US Food and Drug Administ... - https://arstechnica.com/?p=1771616 #alzheimersdrug #clinicaltrials #drugapproval #science #aduhelm #fda
The world finally has an approved vaccine against Ebola - Enlarge / A man receives a vaccine against Ebola from a nurse outside the Afia Himbi Health Center ... more: https://arstechnica.com/?p=1601141 #democraticrepublicofthecongo #infectiousdisease #drugapproval #publichealth #viraldisease #science #vaccine #europe #ebola #virus #who
One dead after poop transplant gone wrong, FDA warns - Enlarge / The Food and Drug Administration headquarters in White Oak, Md. (credit: Getty | Congress... more: https://arstechnica.com/?p=1522487 #fecaltransplant #drugapproval #drugdelivery #microbiome #science #poop #fda