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FDA

FDA
Gilead Release: FDA Approves New Indications For Harvoni And Sovaldi In Pediatric Patients 12 Years And Older With Chronic Hepatitis C Infection
April 7, 2017
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10 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases
April 6, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Teva Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo
April 4, 2017
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2 min read
FDA
What a Day! Genentech Lands FDA Approval for First Drug to Treat Severe Multiple Sclerosis
March 29, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Clears Massachusetts Biotech Tesaro’s Ovarian Cancer PARP Inhibitor
March 27, 2017
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3 min read
FDA
Why Newron Pharma’s Newly Approved Parkinson’s Drug Isn’t All That Novel
March 23, 2017
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1 min read
AstraZeneca PLC Offloads Remaining Anesthetics Portfolio in $766 Million Deal
FDA
FDA Deals Another Blow to AstraZeneca PLC’s Blood Drug
March 17, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Sarepta Under Pressure As Marathon Pharma Emflaza’s Wins FDA Approval for DMD
February 10, 2017
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3 min read
Genentech Grows on Promise of 70+ Drug Approvals
FDA
Genentech’s $94,000-a-Year Drug Tarceva: Why Faster FDA Approvals Could Backfire
February 7, 2017
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4 min read
Investors Sigh With Relief as Biogen's Alzheimer's Drug Delivers in Early-Stage Study
Drug Development
New Spinraza Data Has Biogen Screaming ‘It’s Worth It!’
January 13, 2017
 · 
3 min read
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PRESS RELEASES
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
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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
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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
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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
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2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
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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
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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
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4 min read
Press Releases
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL
February 17, 2026
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6 min read
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