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Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Wowsers! FDA Approves BioMarin’s Brineura, the First Drug for Batten Disease
April 28, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Just Rejected Eli Lilly, Incyte’s Rheumatoid Arthritis Drug Baricitinib
April 14, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Nothing’s Gonna Stop Neurocrine Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults
April 12, 2017
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3 min read
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
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PRESS RELEASES
Press Releases
FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma’s Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim)
July 9, 2026
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9 min read
Press Releases
NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer
July 9, 2026
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5 min read
Press Releases
WuXi Biologics’ MFG8 Drug Substance Facility Secures FDA PLI Approval, Advancing Commercial Supply of a Potential Blockbuster Autoimmune Therapy
July 9, 2026
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4 min read
Press Releases
Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01
July 9, 2026
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8 min read
Press Releases
Octapharma USA Announces Expanded FDA Approval of wilate® for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years
July 8, 2026
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5 min read
Press Releases
Altruist Biologics’ Hangzhou Antibody-Drug Conjugate Facility Receives Provincial Regulatory Approval for Segmented Production
July 8, 2026
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3 min read
Press Releases
Invictus Pharmacy and Mullan Pharmaceutical Inc. Announce Strategic Partnership to Expand Patient Access to FDA-Approved Ganirelix Acetate Injection Through Invictus Pharmacy
July 7, 2026
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7 min read
Press Releases
Vaxart Reports Topline 12-Month Safety Data From the 400-Participant Sentinel Safety Cohort of the Phase 2b Clinical Trial of Its Oral Pill COVID-19 Vaccine
July 7, 2026
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9 min read
Press Releases
AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
July 7, 2026
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19 min read
Press Releases
Genmab Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
July 6, 2026
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10 min read
Press Releases
PharmaEssentia Announces Health Canada Approval of BESREMi® (ropeginterferon alfa-2b) for Polycythemia Vera (PV)
July 6, 2026
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6 min read
Press Releases
Vivos Inc. (OTCQB: RDGL) Receives U.S. FDA Approval for Investigational Device Exemption (IDE) to Initiate Human Clinical Feasibility Study for RadioGel® Precision Radionuclide Therapy™
July 6, 2026
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3 min read
Press Releases
World’s First International Patient Begins Treatment with Newly Approved Solid Tumor CAR-T Therapy at Jiahui International Cancer Center
July 6, 2026
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2 min read
Press Releases
HUTCHMED Announces NMPA Approval for ORPATHYS® for the treatment of Gastric Cancer Patients with MET Amplification
July 2, 2026
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8 min read
Press Releases
Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer
July 2, 2026
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5 min read
Press Releases
[Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer
July 2, 2026
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8 min read
Press Releases
Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)
July 2, 2026
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7 min read
Press Releases
Vertex Announces US FDA Approval for Expanded Use of CASGEVY® for the Treatment of People Ages 2 Years and Older With Sickle Cell Disease or Transfusion-Dependent Beta Thalassemia
July 2, 2026
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11 min read
Press Releases
Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal Hyperplasia
July 1, 2026
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10 min read
Press Releases
Orca Bio’s TREGZI™ Receives U.S. FDA Approval as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies
July 1, 2026
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9 min read
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