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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Keryx Biopharmaceuticals’ Kidney Drug Ferric Citrate With Warnings, Shares Crash
September 8, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Merck & Co.'s New-Kind Of Cancer Drug Keytruda
September 4, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Gaucher Disease Pill Cerdelga
August 19, 2014
 · 
2 min read
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FDA
FDA Approves Biogen Idec, Inc. (Massachusetts)'s Multiple Sclerosis Drug Plegridy
August 18, 2014
 · 
8 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Merck & Co. Wins FDA Approval For New Type Of Sleeping Pill
August 13, 2014
 · 
3 min read
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FDA
FDA Green Lights Boehringer Ingelheim Corporation, Eli Lilly and Company’s Jardiance For Type 2 Diabetes
August 1, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Purdue Pharma L.P.’s Hard-to-Abuse Narcotic Painkiller
July 28, 2014
 · 
2 min read
FDA
First Remote-Control Leg Lengthening Implant Cleared by the FDA, Sinai Hospital Reveals
February 8, 2012
 · 
1 min read
FDA
FDA Told To Reconsider Barr Pharmaceuticals, Inc.'s Morning-After Pill Access
March 24, 2009
 · 
1 min read
FDA
CBER: Substantially Equivalent 510(k) Device Information for CaridianBCT, Inc.
October 22, 2008
 · 
1 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
 · 
9 min read
Press Releases
NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer
July 9, 2026
 · 
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
 · 
4 min read
Press Releases
Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01
July 9, 2026
 · 
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
 · 
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
 · 
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
 · 
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
 · 
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
 · 
10 min read
Press Releases
PharmaEssentia Announces Health Canada Approval of BESREMi® (ropeginterferon alfa-2b) for Polycythemia Vera (PV)
July 6, 2026
 · 
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
 · 
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
 · 
2 min read
Press Releases
HUTCHMED Announces NMPA Approval for ORPATHYS® for the treatment of Gastric Cancer Patients with MET Amplification
July 2, 2026
 · 
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
 · 
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
 · 
8 min read
Press Releases
Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)
July 2, 2026
 · 
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
 · 
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
 · 
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
 · 
9 min read
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