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FDA

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
FDA
Study Shows FDA Deadlines Affect Drug Safety
March 27, 2008
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1 min read
FDA
U.S. Advisers: Restrict Amgen, Johnson & Johnson Anemia Drugs
March 24, 2008
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1 min read
FDA
FDA Gives Itself Okay To Miss Some Drug Approval Deadlines
March 24, 2008
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1 min read
FDA
China Medical Technologies, Inc. Granted CE Mark for ECLIA Analyzer
March 24, 2008
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1 min read
FDA
Tianyin Pharmaceutical Co, Inc. Wins SFDA Approval for Antibiotic
March 17, 2008
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1 min read
FDA
FDA Panel OKs 3 New Flu Strains for Next Year’s Vaccine
February 22, 2008
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1 min read
FDA
More Evidence of Danger From Bayer AG Heart Surgery Drug
February 21, 2008
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1 min read
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PRESS RELEASES
Press Releases
CStone Announces MHRA Approval in UK for Sugemalimab in Stage III NSCLC
February 22, 2026
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6 min read
Press Releases
Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
February 22, 2026
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5 min read
Press Releases
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation
February 22, 2026
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11 min read
Press Releases
FDA Clears FluoGuide’s IND for FG001 in High-Grade Glioma; U.S. Clinical Trial Remains on Track
February 22, 2026
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3 min read
Press Releases
U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults
February 22, 2026
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9 min read
Press Releases
Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept
February 22, 2026
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5 min read
Press Releases
FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
February 20, 2026
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17 min read
Press Releases
FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
February 20, 2026
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8 min read
Press Releases
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
February 20, 2026
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13 min read
Press Releases
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
February 20, 2026
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13 min read
Press Releases
NexEos Bio Announces FDA Clearance of IND Application to Proceed to Phase II/III Trial of NTX-1024 in Vernal Keratoconjunctivitis
February 19, 2026
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3 min read
Press Releases
Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma
February 19, 2026
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4 min read
Press Releases
Sibel Health Receives FDA Acceptance into Drug Development Tool Qualification Program for Innovative Cough Monitoring Sensor
February 19, 2026
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5 min read
Press Releases
Dror Ortho-Design Receives 510(k) FDA Clearance for Next-Generation Smile Correction Solution
February 19, 2026
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8 min read
Press Releases
Breath Diagnostics, Inc. Receives FDA Breakthrough Device Designation for OneBreath™ Platform to Aid Pre-Operative Pneumonia Risk Assessment
February 19, 2026
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6 min read
Press Releases
Garetosmab Biologics License Application Accepted for FDA Priority Review for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
February 19, 2026
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12 min read
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
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