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Boston Scientific receives FDA approval for TheraSphere device
Mar 22, 2021 - Medical Devices Medical Innovations Boston Scientific receives FDA approval for TheraSphere device Medical Device News by Guided Solutions
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Mumbai, Baltimore, June 17, 2021: Global pharma major Lupin Limited (Lupin) today announced that it has received approval for its Sevelamer Hydrochloride...
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RAS Mutation Detection Kit Earns FDA Approval for Panitumumab in CRC | CancerNetwork
May 19, 2026 - Approval of the CRCdx RAS Mutation Detection Kit may improve access to panitumumab for the treatment of patients with colorectal cancer.
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Feb 15, 2024 - Wandercraft has received expanded US Food and Drug Administration (FDA) approval for Atalante X, its self-balancing robotic exoskeleton.
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Regeneron's New Ebola Treatment Just Received FDA Approval - 914INC.
Apr 10, 2026 - Developed with the same methods as President Trump's COVID-19 drug, the antibody cocktail could be a huge leap forward in helping to eradicate the deadly virus.
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Lupin: Caplin receives US FDA approval for generic Rocuronium Bromide Injection, ETHealthworld
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Boston Scientific wins FDA approval for Farapulse cardiac mapping | MedTech Dive
Stifel analyst Rick Wise said Boston Scientific can now offer “one-stop-shopping” with a pulsed field ablation catheter and integrated mapping system to treat...
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Elon Musk's Neuralink gets FDA approval to start clinical trials
May 26, 2023 - Neuralink said its initial goal is to give people with quadriplegia the "ability to control their computers and mobile devices with their thoughts."
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https://www.kuer.org/2020-11-18/pfizer-concludes-coronavirus-vaccine-trial-and-will-seek-fda-approval
Pfizer Concludes Coronavirus Vaccine Trial And Will Seek FDA Approval | KUER
Nov 18, 2020 - A final analysis of Pfizer's clinical trial found its coronavirus vaccine is 95% effective. The drugmaker will now seek the Food and Drug Administration's...
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FDA Approval Is A Game-Changer For Schools Requiring Vaccines For Teachers
Aug 27, 2021 - Teachers and staff members heading back to school this year could be more likely to face an ultimatum: get the vaccine, or find a new job.
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Lawsuit Challenging FDA Approval of Novel Genetically Engineered Color Additive That Makes...
Lawsuit Challenging FDA Approval of Novel Genetically Engineered Color Additive That Makes Impossible Burger "Bleed" Moves Forward ...
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FDA Approval: US FDA approves Elanco's skin disease treatment for dogs, ETPharma
FDA Approval: The oral drug, Zenrelia, aims to control pruritus, or itching, associated with allergic dermatitis and to control atopic dermatitis in dogs that...
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ATS Medical, Inc. Announces FDA Approval of the ATS 3f Aortic Bioprosthesis - BioSpace
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Medtronic submits Hugo soft tissue robot for FDA approval | MedTech Dive
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
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2014 in review: FDA approval of new drugs - WashU Research Profiles
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Med-Chemist: Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)
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Fauci hopeful COVID vaccines will get full FDA approval soon
Aug 9, 2021 - Dr. Anthony Fauci says he is hopeful COVID-19 vaccines will receive full approval by the Food and Drug Administration (FDA) soon.
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FDA Approval of Epoprostenol to Treat Primary Pulmonary Hypertension | The Pulmonary Vascular...
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Fda Approval Articles | IntuitionLabs
Browse articles tagged with "Fda Approval". Find pharmaceutical and life science industry insights related to fda approval.
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Medical Device Regulations | Navigating FDA Approval | Goddard TechnologiesGoddard Technologies
Applying medical device regulations earlier in product development processes helps developers get FDA approval while saving time and costs.
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https://felixvetus.com/news/felixvet-receives-fda-approval-for-clindamycin-hydrochloride-tablets/
Felixvet Receives FDA Approval for Clindamycin Hydrochloride Tablets
Felixvet has secured FDA approval for Clindamycin Hydrochloride Tablets to treat bacterial infections in dogs. Learn more about this reliable treatment option!
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https://www.bioworld.com/articles/690495-scpharmaceuticals-finally-scores-fda-approval-for-sc-loop-diuretic-for-heart-failure?v=preview
Scpharmaceuticals finally scores FDA approval for SC loop diuretic for heart failure | BioWorld
At the third time of asking, Scpharmaceuticals Inc. has seen its subcutaneous loop diuretic, Furoscix (furosemide), approved by the U.S. FDA for patients with...
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Clue Birth Control gets FDA cleared and proven effective by independent scientific research
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Alembic gets FDA approval for Alcaftadine Ophthalmic Solution, ETPharma
Alcaftadine Ophthalmic Solution: The pharma company stated that, "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD),...
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Cellenkos receives FDA approval for CK0801 Phase II clinical trial
Apr 28, 2026 - Cellenkos has received FDA clearance to begin its Phase II clinical trial of CK0801 for the treatment of aplastic anaemia.
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New, Inexpensive IUD Gains FDA Approval - All About Women
May 27, 2022 - In the past few years, Intrauterine Devices (IUDS) have grown increasingly popular with women because of their no-maintenance, long acting and reversible...
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Health Department Reacts to FDA Approval of Pfizer Vaccine
It was announced on Monday that the Food and Drug Administration fully approved the Pfizer Covid-19 vaccine.
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May 4, 2026 - This issue brief details the Alliance of Hippocratic Medicine challenge to the FDA's approval of the abortion pill, mifepristone. It provides context for the...
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https://www.mlo-online.com/home/article/13004821/bayer-gains-fda-approval-for-colon-cancer-drug
Bayer gains FDA approval for colon cancer drug | MLO Online
Bayer AG and Onyx Pharmaceuticals have won U.S. Food and Drug Administration (FDA) approval for the drug regorafenib to treat progressive or metastatic colon...
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FDA Approval: Adagrasib for KRAS G12C NSCLC
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Sofgen's Nimodipine 30mg capsule receives US FDA approval | PharmaTutor
ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, received approval from the US...
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Damona Pharmaceuticals receives FDA approval for DPX-101 trial
Nov 5, 2024 - The US FDA has approved an investigational new drug application from Damona Pharmaceuticals, allowing it to begin a Phase I trial of DPX-101.
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FDA Approval: Sunvozertinib in EGFR Exon 20 NSCLC | IASLC
In this episode of Lung Cancer Considered, host Dr. Stephen Liu discusses EGFR exon 20 insertions and the recently approved targeted therapy for this subset of...
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Apr 12, 2021 - Pfizer could apply for full FDA approval of its COVID-19 vaccine as early as this month, and Moderna could follow soon after. If regulators sign off, that...
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All FDA Approval News and Press Releases from PRWeb
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Hologic wins FDA approval for AI-enabled cervical cancer screening system
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HeartWare Device Wins FDA Approval
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https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma-announces-fda-approval-of-phase-1-2-trial-of-abtl0812-for-patients-with-advanced-metastatic-pancreatic-cancer
AbilityPharma Announces FDA Approval of Phase 1/2 Trial of ABTL0812 for Patients with Advanced...
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FDA grants accelerated approval for Padcev to treat urothelial cancer | 2019-12-19 | BioWorld
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated...
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US FDA expands approval for Travere's drug for rare kidney disease | MarketScreener
Apr 14, 2026 - The U.S. Food and Drug Administration has approved the expanded use of Travere Therapeutics' drug to treat a rare kidney disorder, the company said on Monday....
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Kite gets US FDA approval for Yescarta to treat follicular lymphoma - World Pharmaceutical Frontiers
Mar 8, 2021 - The company claimed that its Yescarta is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma
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Shire Submits Application to the U.S. FDA for Approval of Lifitegrast for Treatment of Dry Eye...
/PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the company has submitted a New Drug Application (NDA) with the U. S. Food and Drug...
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News for Medical Sales Reps: Medtronic First to Receive FDA Approval for Pacing the Heart's Natural...
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Gene therapy for treatment of adults with Hemophilia B receives FDA approval | HPN Online
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Pixel Watch 3's Groundbreaking Pulse Loss Detection Gets FDA Approval | HotHardware
Feb 27, 2025 - A big, potentially life-saving feature is coming to a Google Pixel Watch 3 near you. Loss of pulse detection is coming to U.S. users by end of March following...
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Supporting opioid risk assessment: FDA grants SOLVD Health PMA supplement approval | MLO Online
This approval enhances opioid risk assessment capabilities by allowing the INFINITI HTS to process 20 times more samples daily.
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Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve...
Nov 8, 2011 - Already approved in Europe since March 2010, Edwards' Sapien XT valve now gains further investigational device study arm in USA.
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Arizona Bioscience News: UA CAMI groundbreaking; Caris Life Science FDA approval; Hispanic...
Nov 22, 2024 - Arizona Bioscience News: UA CAMI groundbreaking; Caris Life Science FDA approval; Hispanic Alzheimer's
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J&J, Pharmacyclics Cancer Drug Wins FDA Approval; $91 Per Pill Pricetag | Pharma Manufacturing
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Powerful Narcotic Painkiller Up For FDA Approval
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AAVantgarde Announces FDA Orphan Drug Designation and UK CTA approval for AAVB-039 for the...
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FDA Considers Approval of Cancer-causing Contraception for Sale Over the Counter (RAN) -...
Jan 15, 2026 - On May 10, fears of chemical abortion restriction is causing the FDA to consider approval of the cancer-causing contraceptive pill for sale over the counter,...
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FDA Stops Emergency Approval For Use Of Blood Plasma In Covid-19 - WorldHealth.net
Aug 20, 2020 - The FDA was in the process to allow the emergency use of blood plasma donation from those who have recovered from COVID-19. However, this authorization has...
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Jul 5, 2021 - Welcome to The Daily Wrap Up, dedicated to bringing you the most relevant independent news, as we see it, from the last 24 hours (7/4/21).
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ASG Receives U.S. FDA IND Approval to Initiate Phase 1 Clinical Trial of the Lead Drug Beta1 for...
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HIV prevention drug hailed as a 'breakthrough' gets FDA approval | Wyoming Public Media
Jun 18, 2025 - A drug called lenacapavir, administered in two injections a year, offers protection from HIV comparable to daily pills. One looming question: Will it be...
https://jonfleetwood.substack.com/p/fda-to-skip-drug-approval-process/comments
Comments - FDA to Skip Drug Approval Process for Bird Flu Vaccine: Dr. Peter Marks Confirms Agency...
"We have plans to... if necessary use emergency use authorization if we had to [in order] to ensure that we could get countermeasures out as quickly as...
https://blog.healthverity.com/how-the-fda-is-using-real-world-evidence-in-safety-and-approval-decisions
How the FDA is using real-world evidence in safety and approval decisions
How the FDA uses real-world evidence for safety surveillance and approvals, including Sentinel studies and what regulatory-ready data requires.
real world evidence
https://www.nhpr.org/national/2020-11-18/pfizer-concludes-coronavirus-vaccine-trial-and-will-seek-fda-approval
Pfizer Concludes Coronavirus Vaccine Trial And Will Seek FDA Approval | New Hampshire Public Radio
Jun 17, 2021 - A final analysis of Pfizer's clinical trial found its coronavirus vaccine is 95% effective. The drugmaker will now seek the Food and Drug Administration's...