https://hirekhan.com/blog/2026/02/05/us-fda-otc-drug-registration-complete-guide-for-over-the-counter-drug-compliance/
US FDA OTC Drug Registration: Complete Guide for Over-the-Counter Drug Compliance - Global...
Feb 5, 2026 - Over-the-counter (OTC) drugs are widely sold in the United States without a prescription, but they are still subject to strict regulatory control. Any company
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https://bioutah.org/us-fda-510k-clearance-and-clia-waiver-for-the-fast-and-innovative-biofire-spotfire-system-and-its-biofire-spotfire-respiratory-r-panel/
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and...
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https://www.celltrionusa.com/history-event/inflectra-receives-approval-by-us-fda/
Inflectra receives approval by US FDA - Celltrion USA
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https://www.biospectrumindia.com/news/95/5287/pfizer-seeks-us-fda-approval-for-its-new-drug.html
Pfizer seeks US FDA approval for its new drug
Pfizer has announced that it has submitted New Drug Application (NDA) to the US regulator
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https://optimaldose.ciscientists.com/news-1-18/
IND approval for LM-350 “CDH17 ADC” from the US FDA - Optimal Dose
Jul 25, 2025 - Weekly Digest - July 2025 Weekly Digest - July 2025 24 July 2025: IND approval for LM-350 “CDH17 ADC” from the US FDA Sino Biopharmaceutical’s subsidiary,...
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https://www.daily.thekable.news/p/lupin-recruits-from-the-us-fda-novartis-to-build-capability-in-ksa-regeneron-pays-sanofi-to-break-up-the-kable-celebrates-100
💉 Lupin recruits from the US FDA; Novartis to build capability in KSA; Regeneron pays Sanofi to...
Mar 23, 2023 - RA drugs might reduce Covid deaths
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https://demo.wockhardt.com/investor/wockhardt-receives-us-fda-qualified-infectious-disease-product-designation-for-wck-6777-a-first-ever-once-a-day-ss-lactam-enhancer-class-antibiotic/
WOCKHARDT RECEIVES US FDA QUALIFIED INFECTIOUS DISEASE PRODUCT DESIGNATION FOR WCK 6777, A FIRST...
Wockhardt is a leading, research-based global enterprise in pharmaceuticals, biotechnology and healthcare services.
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https://hamletbiopharma.com/hamlet-biopharma-holds-successful-in-person-meeting-with-us-fda/
Hamlet BioPharma Holds Successful In Person Meeting with US FDA - Hamlet BioPharma
Oct 8, 2025 - Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, today announces the successful first...
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https://pharmabiz.com/ArticleDetails.aspx?aid=186022&sid=2
US FDA & Japan’s MHLW accept Bayer’s FXIa inhibitor, asundexian for prevention of ischemic stroke
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https://friendsofcancerresearch.org/news/pink-sheet-has-rd-productivity-rebounded-us-fda-officials-think-so/
Pink Sheet - Has R&D Productivity Rebounded? US FDA Officials Think So - Friends of Cancer Research
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https://certatherapeutics.com/certa-therapeutics-ft011-granted-us-fda-orphan-drug-designation-for-the-treatment-of-systemic-sclerosis/
Certa Therapeutics’ FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic...
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https://webarchive.library.unt.edu/eot2008/20090511165438mp_/http:/www.cfsan.fda.gov/~lrd/pestadd.html
US FDA/CFSAN - Pesticides, Metals and Industrial Chemicals
Pesticides, Metals and Industrial Chemicals, including lead, mercury, acrylamide, dioxins, PCBs, furan, perchlorate, radionuclides, methodology for drug and...
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https://www.motilaloswal.com/news/stocks/109551
Lupin clears US FDA inspection of Nagpur facility with zero issues | Motilal Oswal
Lupin's Nagpur facility passed a US FDA inspection with "No Observations" after a 4-day inspection from November 10 to 14, 2025. This is a zero-FDA ...
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https://pharmashots.com/33881/astrazenecas-truqap-combination-receives-the-us-fda-approval-for-pten-deficient-mapmn-s-prostate-cancer/
AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate...
Jun 15, 2026 - Explore the approval of Truqap for prostate cancer treatment. Learn about its benefits with abiraterone and ADT.
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https://www.inspiring-training.com.my/tag/tag_id/276543,276524,306854,276542/
US FDA Johor Bahru (JB), Malaysia, Southkey | Inspiring Training & Consultancy Plt
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https://newsonspot.com.ng/2023/12/11/us-fda-approves-two-gene-therapies-for-sickle-cell-disease/
US FDA Approves Two Gene Therapies For Sickle Cell Disease... - News On Spot
Dec 11, 2023 - The U.S. Food and Drug Administration (FDA) on Friday approved two gene therapies for sickle cell disease, making one of
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https://plasticsurgerypractice.com/treatment-solutions/products/u-s-fda-approves-juvederm-ultra-xc-lip-plumping/
US FDA Approves JUVEDERM® ULTRA XC for Lip Plumping - Plastic Surgery Practice
Oct 1, 2015 - The US Food and Drug Administration (FDA) has given its nod to Allergan's JUVÉDERM® ULTRA XC for lip augmentation in adults over the age of 21.
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https://www.pressrelease.com/news/nx-development-corp-is-granted-orphan-drug-designation-status-by-us-22260331
NX Development Corp. is Granted Orphan-Drug Designation Status by US FDA for Gleolan® in Ovarian...
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https://mydhl.express.dhl/mn/en/help-and-support/shipping-advice/what-can-i-ship/importing-food-to-us.html
Guide to importing food to the US, FDA regulations for shipping food
Shipping food to the US and FDA regulatons for shipping food
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https://auroracos.com/help/can-i-sell-these-products-in-the-us-fda-and-eu-cpnp/
Can I Sell in US (FDA) and EU (CPNP)? Global Compliance
Feb 6, 2026 - Expand globally with confidence. Our formulas are designed to meet FDA (MoCRA) and EU (CPNP) safety regulations for international sales.
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https://www.peptidetrace.com/pseo/desmopressin-legal-status-us
Desmopressin Legal Status in the US: FDA Approval & Regulation — PeptideTrace
Desmopressin is FDA-approved in the US for specific medical conditions. Learn its legal status, approved uses, and regulatory framework.
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https://pharmashots.com/31686/astrazenecas-calquence-regimen-receives-the-us-fda-approval-for-chronic-lymphocytic-leukemia-cll/
AstraZeneca’s Calquence Regimen Receives the US FDA Approval for Chronic Lymphocytic Leukemia (CLL)...
Feb 23, 2026 - Calquence has been approved for adults with CLL, showing promising trial results. Find out more about this important treatment.
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NMP US-FDA 醫材等級膠原蛋白原料 (Low Endotoxin)-星月基因有限公司
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https://www.zirconiachmgroup.com/products/portable-ipl-aesthetic-device-us-fda-approved/
Portable IPL Beauty Device (US FDA Approved)
SPTF+ - Advanced IPLIntroduction:GSD Plus is a portable IPL machine upgraded from GSD sPTF. Its advantages include a streamlined operating system
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https://www.qrcode-tiger.com/fda-udi-medical-device-qr-codes-gs1
US FDA UDI: How Medical Device QR Codes Work with GS1 | QR Tiger
Medical device QR codes work under strict FDA UDI rules. See how GS1 DataMatrix carries the primary UDI and QR codes to support eIFU and recall content. - QR...
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https://www.businesstimes.com.sg/international/increased-risk-of-rare-nerve-disorder-after-jj-covid-vaccine-us-fda
'Increased risk' of rare nerve disorder after J&J Covid vaccine: US FDA - The Business Times
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https://www.sightsciences.com/ous/sight-sciences-receives-full-investigational-device-exemption-ide-approval-from-the-us-fda-to-initiate-the-visco360-versus-slt-glaucoma-trial/
Sight Sciences Receives Full Investigational Device Exemption (IDE) Approval from the US FDA to...
Sep 22, 2016 - Sight Sciences, Inc., a venture-backed, commercial-stage ophthalmic medical device company announced today that it has received full IDE approval from the FDA...
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https://www.medicinesresources.nhs.uk/us-fda-grants-ipi-549-in-combination-with-nivolumab-fast-track-designation-for-the-treatment-of-advanced-urothelial-cancer.html
US FDA grants IPI-549 in combination with nivolumab Fast Track Designation for the treatment of...
IPI-549 is a first-in-class oral medicine that selectively inhibits PI3K-gamma. It is currently being investigated in the global Phase II MARIO-275 study, in...
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https://www.2gb.com/imugene-cancer-drug-trial-green-lit-by-us-fda/
Imugene: Cancer drug trial green lit by US FDA
May 25, 2023 - Listen to ASX-listed Imugene Managing Director Leslie Chong talk to Matt Birney on the Bulls N’ Bears Report about Imugene’s “immunotherapy” drug that can...
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https://globalwiselink.com/service/beimei46/146.html
US(FDA) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction
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https://pharmashots.com/33737/pfizer-receives-the-us-fda-approval-for-hympavzi-to-treat-hemophilia-a-or-b-in-two-populations/
Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations -...
Jun 9, 2026 - Learn about Hympavzi, approved by the US FDA for treating hemophilia A and B in patients aged 12 years and older.
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https://www.pharmaindustrial-india.com/news/viatris-wins-us-fda-approval-for-once-weekly-gwyn-lo-contraceptive-patch
Viatris Wins US FDA Approval for Once-Weekly Gwyn Lo Contraceptive Patch - Regulation
Viatris Wins US FDA Approval for Once-Weekly Gwyn Lo Contraceptive Patch - Regulation
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https://www.syneurx.com/zh/2021-03-26/
US FDA Approves SyneuRx’s IND Application for a Phase II Clinical Trial for Adult Patients with...
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https://miratag.com/es/checklist-templates/bakery-daily-production-checklist-us
Free Bakery Daily Production Checklist (US / FDA)
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https://www.expresspharma.in/what-us-fdas-new-surprise-foreign-inspections-plan-means-for-india/
What US FDA's new surprise foreign inspections plan means for India - Express Pharma
Jun 3, 2025 - Pharma companies exporting to the US should now rightly be on guard and start preparing for the inevitable “knock on the factory gate”
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https://www.universalcurrentaffairs.com/2025/06/us-fda-approves-gileads-twice-yearly.html
US FDA approves Gilead's twice-yearly injection for HIV prevention. ~ CURRENT AFFAIRS (CA) DAILY...
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https://www.drpaulalexander.com/files/-calling-off-hunters_eu2b4whzdpbbrsyirhkdqz
I knew other agencies in US government like CDC, NIH, FDA etc. were co – Dr. Paul Alexander
cocaine, missing cocaine, found cocaine investigation, saying there is no physical evidence, and I have heard interviewed not one person...how much more...
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https://www.freyrsolutions.com/pl/food-supplements/us-fda-food-facility-registration
Rejestracja zakładu spożywczego w US FDA, rejestracja żywności w US FDA
Freyr zapewnia wsparcie w zakresie rejestracji zakładów spożywczych w US FDA oraz powiadomień GRAS dla firm produkujących żywność w celu skutecznego wejścia na...
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https://www.whysports.co.uk/post/the-us-fda-has-given-clearance-for-a-new-feature-on-the-apple-watch-to-allow-users-to-monitor-hypert
The US FDA has given clearance for a new feature on the Apple Watch to allow users to monitor...
Sep 26, 2025 - Available on the Apple Watch Series 9, 10, and 11 and Ultra 2 and 3 models, the new feature can alert users if signs of chronic high blood pressure are...
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https://ginoctnews.com/detail/26ddddafb0c2cb1eff73732f9f707456
US FDA panel to weigh bid to market nicotine pouches as lower-risk than cigarettes
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https://d2233.cms.socastsrm.com/2026/09/28/astrazeneca-files-us-fda-application-for-hutchmed-lung-cancer-drug-combination/
AstraZeneca files for US FDA approval of HUTCHMED lung cancer drug combination | MWC...
Sept 29 (Reuters) - HUTCHMED (China) said on Tuesday that Anglo-Swedish drugmaker AstraZeneca had applied to the US Food and Drug Administration for approval...
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https://www.foodingredientsfirst.com/news/us-fda-greenlights-avantiums-plant-based-polymer-in-food-safe-packaging.html
US FDA greenlights Avantium’s plant-based polymer in food-safe packaging
The US Food and Drug Administration granted Avantium Food Contact Notification approval for the use of its polyethylene furanoate (PEF) in food contact articles
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https://thenationalpolicy.com/us-fda-approves-astrazeneca-amgen-drug-for-severe-asthma/
US FDA approves AstraZeneca-Amgen drug for severe asthma – The National Policy
The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, US
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https://www.nutritioninsight.com/news/sports-nutrition-energy-recovery-orange-extract-fda-solabia.html
US FDA approves Solabia Nutrition’s patented orange extracts for sports nutrition and recovery
The US FDA has issued an approval letter regarding the GRAS status of Solabia Nutrition’s two orange extracts for sports nutrition and energy.
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https://pharmapress.co.uk/brands/ddd/5388/
Kali Therapeutics Receives US FDA Clearance for KT501 Investigational New Drug Application |...
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https://www.citizen-news.org/2021/08/video-all-tobacco-products-cause.html
CNS: [video] All tobacco products cause preventable diseases, avoidable deaths | US FDA bans 55000...
CNS is committed to rights-based communication, policy and advocacy for development justice (health, gender, economic, social, and climate justices)
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https://www.thepharmaletter.com/pharma-news/bioalliance-pharma-s-sitavig-oked-by-us-fda-for-herpes-labialis
BioAlliance Pharma's Sitavig OKed by US FDA for Herpes labialis | Pharmaceutical | The Pharmaletter
French drugmaker BioAlliance Pharma (Euronext Paris - BIO) has received marketing authorization from the US Food and Drug Administration for Sitavig (acyclovir
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https://pharmacy.mahidol.ac.th/dic/news_week_full.php?id=577
US. FDA เลื่อนการจำหน่าย Alogliptin
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https://pharmashots.com/33172/briacell-therapeutics-reports-us-fda-ind-clearance-to-initiate-p-i-ii-trial-of-bria-bres-in-breast-cancer/
BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast...
May 6, 2026 - Bria-BRES+ gains FDA clearance for trials in metastatic breast cancer. Learn about its potential and efficacy in our latest post.
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https://www.thepharmaletter.com/us-fda-set-for-even-fewer-approvals-in-2008
US FDA set for even fewer approvals in 2008 - Pharmaceutical industry | The Pharmaletter
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https://www.pharmaceutical-technology.com/news/newsus-fda-grants-priority-review-to-novartis-leukaemia-drug-5669307/
US FDA grants priority review to Novartis' leukaemia drug - Pharmaceutical Technology
Nov 14, 2016 - Novartis PKC412 (midostaurin) new drug application (NDA) has received Priority Review from the US Food and Drug Administration (FDA).
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