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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AbbVie, Genentech Leukemia Drug Wins Breakthrough Status Tag
May 7, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Business
AcelRx Crashes as the FDA Rejects Request for Meeting on Pain Drug Device
May 4, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
GlaxoSmithKline Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients
May 1, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amgen’s T-Vec Cancer Therapy Gets FDA Panel OK
April 30, 2015
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Kythera Grabs FDA Approval for Chin Fat-Busting Drug
April 30, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Analysts Cheer As Amgen Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor
April 16, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Gilead’s Next-Gen HIV Drug Heads to the FDA, Stock Soars
April 8, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Clovis Oncology Shares Leap as FDA Deems Ovarian Cancer Drug a Breakthrough, Company Preps for ARIEL3
April 7, 2015
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2 min read
FDA
Berry Genomics NextSeq CN500 Instrument And Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance
March 31, 2015
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs GlaxoSmithKline, Theravance’s Breo for Adults, Not Kids
March 20, 2015
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2 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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