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FDA

A Novo Nordisk flag flies in the wind/Courtesy jor
FDA
Eli Lilly Looks Over Its Shoulder After Novo Nordisk Wins FDA Panel Backing for Diabetes Drug
An advisory panel with the FDA gave a near unanimous support to Novo Nordisk’s diabetes drug semaglutide, a long-acting GLP-1 analogue.
October 19, 2017
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2 min read
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Alex Keown
Gilead's $12B Bet Pays Off in Two Months After the
FDA
Gilead’s $12B Bet Pays Off in Two Months After the FDA Approves Kite’s Revolutionary CAR-T Therapy
Maybe timing is everything. On Aug. 28, 2017, Gilead acquired Kite for about $11.9B.
October 18, 2017
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3 min read
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Mark Terry
FDA
BioPharm Executive: The Rockville Files
Officially, there have been four new chemical entities have been approved since our last issue.
October 14, 2017
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1 min read
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Karl Thiel
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Amgen, Allergan Make History With First Cancer Biosimilar OK—Will Take on Genentech’s $6 Billion Best-Seller
September 15, 2017
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3 min read
Gecko Biomedical is Expanding Following Marketing Approval of its Vascular Sealant
FDA
Gecko Biomedical is Expanding Following Marketing Approval of its Vascular Sealant
September 12, 2017
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3 min read
Novartis to Hold On to Its 33% Stake in Roche—For Now
FDA
Novartis AG Waltzes to the Finish Line With First Ever FDA Approval for CAR-T
August 30, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Adamas Wins FDA OK for the First and Only Drug for Parkinson’s Dyskinesia Drug
August 25, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA
August 18, 2017
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
FDA Green Lights Pfizer Drug for Rare, Fast-Killing Type of Leukemia
August 18, 2017
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2 min read
FDA
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study
August 17, 2017
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1 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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