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Approvals

FDA
Industry Goes on Offense on Medical Device Approvals, AdvaMed
September 5, 2008
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1 min read
FDA
FDA Clears Test to Help Doctors Manage Heart Transplant Patients
August 27, 2008
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1 min read
FDA
FDA On Pace To Approve 18 New Drugs In 2008
August 8, 2008
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1 min read
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
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PRESS RELEASES
Press Releases
BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma
May 14, 2026
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10 min read
Press Releases
ZEISS expands ophthalmic surgical workflows in Mexico with COFEPRIS approval for ARTEVO 850 and MICOR 700
May 13, 2026
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5 min read
Press Releases
European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors
May 13, 2026
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16 min read
Press Releases
Femasys Expands Fertility Care Portfolio in Europe with CE Mark Approval for FemHSG™ Catheter
May 13, 2026
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5 min read
Press Releases
Silexion Therapeutics Announces Initiation of GMP Clinical Supply Manufacturing of SIL204 with Leading Global CDMO, and New Approval of Phase 2/3 Trial From Tel Aviv Sourasky Medical Center
May 13, 2026
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7 min read
Press Releases
Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody
May 13, 2026
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3 min read
Press Releases
Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update
May 12, 2026
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24 min read
Press Releases
Orion Animal Health receives US FDA approval for Tessie® (tasipimidine oral solution) for the treatment of noise aversion and separation anxiety in dogs
May 12, 2026
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3 min read
Press Releases
ProBio and Curocell Achieve Key CAR-T Milestone with BLA Regulatory Approval and Commercial Readiness
May 11, 2026
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5 min read
Press Releases
LIB Therapeutics Launches LEROCHOL® (lerodalcibep-liga) in the United States with a Patient-First Approach to Access and Affordability
May 11, 2026
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6 min read
Press Releases
Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher
May 11, 2026
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12 min read
Press Releases
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
May 10, 2026
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2 min read
Press Releases
argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 10, 2026
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14 min read
Press Releases
Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell Carcinoma
May 8, 2026
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9 min read
Press Releases
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
May 8, 2026
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18 min read
Press Releases
InnoCare Announces Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Sjögren’s Syndrome in China
May 8, 2026
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3 min read
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
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4 min read
Press Releases
Scienture Secures $11.0 Million in Non-Dilutive Debt Financing to Accelerate Growth of Approved Product Portfolio and Advancement of R&D Pipeline
May 7, 2026
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11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
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3 min read
Press Releases
Avacta presents new comparisons of pre|CISION® payload release vs approved ADCs and AVA6207 dual payload delivery at Science Day 2026
May 6, 2026
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5 min read
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