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FDA

Genentech Grows on Promise of 70+ Drug Approvals
Drug Development
Genentech’s Lung Cancer Drug Alecensa Gets 2nd FDA Breakthrough Status
October 4, 2016
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2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
FDA Clears Amgen Copy of AbbVie’s Blockbuster Humira
September 26, 2016
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3 min read
Did FDA Just Destroy Its Credibility?
FDA
BioPharm Executive: Did the FDA Just Destroy Its Credibility?
September 23, 2016
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5 min read
FDA
Approving A Muscular Dystrophy Drug Exposes A Civil War At The FDA
September 20, 2016
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1 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
Meet the Powerful Woman Behind the Scenes of Sarepta’s DMD Drug Approval
September 20, 2016
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4 min read
M&A Speculation Begins as Sarepta CEO Puts In His Notice
FDA
Victory at Last! Sarepta Stock Doubles as the FDA Finally Approves DMD Drug
September 19, 2016
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Clovis Oncology Stock Jumps as FDA Skips Review Panel for New Cancer Drug
September 9, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Another Celgene Bet Pays Off as Agios Eyes Early Approval of Leukemia Drug
September 7, 2016
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2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
Amgen Remains Hush-Hush Over FDA Rejection of Parsabiv
August 25, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Bay Area’s Portola Plummets as FDA Rejects AndexXa NDA
August 18, 2016
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3 min read
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PRESS RELEASES
Press Releases
Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
February 17, 2026
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1 min read
Press Releases
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
February 17, 2026
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1 min read
Press Releases
Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
February 17, 2026
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10 min read
Press Releases
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
February 17, 2026
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32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
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13 min read
Press Releases
Novo Nordisk A/S: The European Commission approves more effective dose of injectable Wegovy® for adults with obesity; clinical study showed people lost about 21% of their body weight on average
February 17, 2026
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4 min read
Press Releases
Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL
February 17, 2026
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6 min read
Press Releases
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Iberdomide in Patients with Relapsed or Refractory Multiple Myeloma
February 17, 2026
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6 min read
Press Releases
Cytokinetics Announces European Commission Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
February 17, 2026
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9 min read
Press Releases
Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
February 17, 2026
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2 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
February 17, 2026
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5 min read
Press Releases
Cyclerion Therapeutics Announces Progress Toward CYC-126 Phase 2 Proof-of-Concept Study with FDA Feedback and Formation of Clinical Advisory Board
February 17, 2026
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12 min read
Press Releases
Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser
February 17, 2026
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4 min read
Press Releases
LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System
February 16, 2026
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2 min read
Press Releases
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
February 16, 2026
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4 min read
Press Releases
Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
February 15, 2026
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7 min read
Press Releases
MEDIPOST Inc. Submits IND Amendment With U.S. Food and Drug Administration to Initiate Phase III Trial
February 13, 2026
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1 min read
Press Releases
Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery
February 13, 2026
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4 min read
Press Releases
InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device
February 13, 2026
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2 min read
Press Releases
HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer
February 13, 2026
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5 min read
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