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FDA

FDA
FDA Approves 2008-2009 Season’s Flu Vaccines: CSL Limited, Afluria. GlaxoSmithKline Biologicals, Fluarix. ID Biomedical Corporation of Quebec, FluLaval. MedImmune Vaccines, FluMist. Novartis Vaccines & Diagnostics, Inc., Fluvirin. Sanofi Pasteur, Fluzone.
August 6, 2008
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1 min read
FDA
CDRH Updates:: Invitrogen Corporation SPOT-Light(R) HER2 CISH(TM) Kit - P050040 Approval
August 1, 2008
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1 min read
FDA
FDA (JOBS) Panel: No Black Box Warning On Epilepsy Drugs
July 11, 2008
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1 min read
FDA
Drugmakers Agree to Wait on Advertising New Drugs; Congressional Hearing Focused on Pfizer Inc.'s Lipitor, Johnson & Johnson’s Procrit, and Vytorin Sold by Merck & Co., Inc. and Schering-Plough Pharmaceuticals
June 18, 2008
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1 min read
FDA
Simcere Pharmaceutical Group Given SFDA Approval for Generic Antibiotic
May 14, 2008
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1 min read
FDA
China Biologic Products Reports Two SFDA Successes
May 1, 2008
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1 min read
FDA
Overview of FDA Meeting on Embryonic Stem Cells
April 28, 2008
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1 min read
FDA
Pharmaceutical Safety: If A Drug Has FDA’s OK, Should You Be Able To Sue? -- Editorial, Opinion Piece
April 28, 2008
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1 min read
FDA
Sinovac Biotech Ltd. Granted SFDA Approval for Avian Flu Vaccine
April 2, 2008
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1 min read
FDA
Oculus Innovative Sciences, Inc. Announces SFDA Approval of Microcyn
March 31, 2008
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1 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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