https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
Drug Approvals and Databases | FDA
CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers...
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https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2021
Novel Drug Approvals for 2021 | FDA
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public
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https://chembl.blogspot.com/2010/11/2010-new-drug-approvals-pt-xvii.html
2010 New Drug Approvals - Pt. XVII- Eribulin Mesylate (Halaven)
ATC code (partial): L01C On November 15th, 2010, the FDA approved Eribulin Mesylate (ResearchCode:E-7389) under the trade name Hal...
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https://chembl.blogspot.com/2011/05/new-drug-approvals-2011-pt-xiv.html
New Drug Approvals 2011 - Pt. XIV Boceprevir (VictrelissupTM/sup)
ATC code (partial): J On May 13 th , the FDA approved Boceprevir (Tradename: Victrelis ; Research Code: SCH-503034, NDA2022...
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https://chembl.blogspot.com/2013/09/new-drug-approvals-2013-pt-xiii.html
New Drug Approvals 2013 - Pt. XIII - Dolutegravir (TivicaysupTM/sup)
ATC code: J05AX12 On 12 August, the FDA approved a further drug for the treatment of HIV-1 infection, Dolutegravir (Tradename: T...
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Predict Drug Approvals Before the Market
Evidence-based probability scores for FDA drug approvals. Real-time analysis from ClinicalTrials.gov, OpenFDA adverse events, and SEC regulatory filings.
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https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022
Novel Drug Approvals for 2022 | FDA
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
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https://www.fool.com/investing/2020/05/28/fda-says-covid-19-could-delay-drug-approvals.aspx
FDA Says COVID-19 Could Delay Drug Approvals | The Motley Fool
May 28, 2020 - The pandemic is pulling the agency in different directions.
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https://chembl.blogspot.com/2012/05/new-drug-approvals-2012-pt-xi.html
New Drug Approvals 2012 - Pt. XI - Taliglucerase alfa (ElelysosupTM/sup)
ATC code : A16AB11 Wikipedia : Taliglucerase alfa On May 1, the FDA approved taliglucerase alfa for the treatment of Ty...
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https://chembl.blogspot.com/2010/06/2010-new-drug-approvals-pt-vi.html
2010 New Drug Approvals - Pt. VI - Polidocanol (Asclera)
ATC code: C05BB02 On March 30th, the FDA approved Polidocanol under the trade name Asclera. Polidocanol is a sclerosing agent indicated...
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https://www.fda.gov/drugs/first-generic-drug-approvals/anda-generic-drug-approvals-2016
ANDA (Generic) Drug Approvals in 2016 | FDA
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https://chembl.blogspot.com/2010/11/2010-new-drug-approvals-pt-xiv.html
2010 New Drug Approvals - Pt. XIV - Dabigatran etexilate (Pradaxa)
ATC Code: B01AE07 Dabigatran etexilate has been approved by the FDA on October 19th 2010. Dabigatran etexilate (also known as BIBR-1048 f...
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https://chembl.blogspot.com/2012/11/new-drug-approvals-2012-pt-xxiii.html
New Drug Approvals 2012 - Pt. XXIII - Omacetaxine mepesuccinate (SYNRIBOsupTM/sup)
ATC code: L01XX40 Wikipedia: Omacetaxine_mepesuccinate On October 22nd 2012 the FDA approved omacetaxine mepesuccinate (res...
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https://chembl.blogspot.com/2013/01/new-drug-approvals-2012-pt-xxxv_27.html
New Drug Approvals 2012 - Pt. XXXV - Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil...
Elvitegravir: Cobicistat: ATC Code : J05AR09 Wikipedia : Elvitegravir/Cobicistat /Emtricitabine/Tenofovir O...
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https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1028324
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https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1784
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https://pmc.ncbi.nlm.nih.gov/articles/PMC10148199/?ref=levernews.com
Comparison of Research Spending on New Drug Approvals by the National Institutes of Health vs the...
How does National Institutes of Health (NIH) investment in pharmaceutical innovation compare with investment by the pharmaceutical industry? In this...
https://petrieflom.law.harvard.edu/2016/06/17/thoughtful-creates-act-may-help-speed-generic-drug-approvals/
Thoughtful CREATES Act May Help Speed Generic Drug Approvals - Petrie-Flom Center
Oct 30, 2025 - By Rachel Sachs Earlier this week, a bipartisan group of Senators introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a...
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https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=847721
Search Orphan Drug Designations and Approvals
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https://boris-portal.unibe.ch/entities/publication/c94fee94-e133-4bf5-8978-cb06d5e075ed
The Evidence Base of US Food and Drug Administration Approvals of Novel Cancer Therapies from 2000...
Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for...
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https://invivoblog.blogspot.com/2008/07/rems-to-rescue-why-fdas-drug-safety.html?showComment=1218036600000
The IN VIVO Blog: REMS to the Rescue? Why FDA's Drug Safety Tools May Mean More Approvals This Year
The statistics aren't encouraging: fewer new drugs approved by FDA so far this year than last--and last year was arguably the worst year all...
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https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=760720
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https://www.fda.gov/patients/learn-about-drug-and-device-approvals
Learn About Drug and Device Approvals | FDA
FDA is speeding up the approval process for Drugs and Medical Devices. Learn how medical products are approved.
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https://journals.ku.edu/rrnmf/article/view/21232
A Worsening Problem in ALS: Insurance Barriers Between Drug Approvals and Patient Access | RRNMF...
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https://pubmed.ncbi.nlm.nih.gov/35798555/
Prostate Cancer Theranostics: Concurrent Approvals by the Food and Drug Administration of the First...
Prostate Cancer Theranostics: Concurrent Approvals by the Food and Drug Administration of the First Diagnostic Imaging Drug Indicated to Select Patients for a...
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