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FDA

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA
August 18, 2017
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
FDA Green Lights Pfizer Drug for Rare, Fast-Killing Type of Leukemia
August 18, 2017
 · 
2 min read
FDA
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study
August 17, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
This is What Happens When the FDA Approves Cancer Drugs Too Quickly
August 17, 2017
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3 min read
AbbVie Leaps Into the Land of Oncolytics With New Turnstone Biologics Tie-Up
FDA
AbbVie Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C
August 4, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Advisory Panel Votes Against Approval Of Johnson & Johnson’s Sirukumab
August 3, 2017
 · 
2 min read
FDA
Blood Markers Of Chronic Fatigue Syndrome Could Pave The Way To A Diagnostic Test, Stanford Reveals
August 2, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Agios, Celgene Win Early FDA Approval for New Cancer Drug
August 1, 2017
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2 min read
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
FDA
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
August 1, 2017
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2 min read
Gilead Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
FDA
FDA Green Lights Gilead’s Vosevi, With a Black Box Warning Attached
July 19, 2017
 · 
2 min read
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PRESS RELEASES
Press Releases
FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
February 18, 2026
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8 min read
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
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3 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
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3 min read
Press Releases
Maestro MEA Platform Powers First Stem Cell Cardiac Safety Assay in FDA ISTAND Program
February 18, 2026
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3 min read
Press Releases
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
February 18, 2026
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2 min read
Press Releases
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
February 18, 2026
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26 min read
Press Releases
Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance
February 18, 2026
 · 
4 min read
Press Releases
Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
February 18, 2026
 · 
8 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
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2 min read
Press Releases
FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction
February 18, 2026
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8 min read
Press Releases
Beta Bionics Announces Fourth Quarter and Full Year 2025 Financial Results and Introduces Annual Guidance for Full Year 2026
February 18, 2026
 · 
16 min read
Press Releases
Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older
February 17, 2026
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2 min read
Press Releases
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
February 17, 2026
 · 
2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
 · 
13 min read
Press Releases
Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
February 17, 2026
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1 min read
Press Releases
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
February 17, 2026
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1 min read
Press Releases
Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
February 17, 2026
 · 
10 min read
Press Releases
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
February 17, 2026
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32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
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13 min read
Press Releases
Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average
February 17, 2026
 · 
4 min read
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