SUBSCRIBE
SUBSCRIBE

FDA

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!
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
Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!
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
FDA
FDA Delays: Hurry Up and Wait
September 23, 2008
 · 
1 min read
FDA
Industry Goes on Offense on Medical Device Approvals, AdvaMed
September 5, 2008
 · 
1 min read
FDA
FDA Clears Test to Help Doctors Manage Heart Transplant Patients
August 27, 2008
 · 
1 min read
Load More
PRESS RELEASES
Press Releases
FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
February 18, 2026
 · 
8 min read
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
 · 
3 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
 · 
3 min read
Press Releases
Maestro MEA Platform Powers First Stem Cell Cardiac Safety Assay in FDA ISTAND Program
February 18, 2026
 · 
3 min read
Press Releases
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
February 18, 2026
 · 
2 min read
Press Releases
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
February 18, 2026
 · 
26 min read
Press Releases
Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance
February 18, 2026
 · 
4 min read
Press Releases
Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
February 18, 2026
 · 
8 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
 · 
2 min read
Press Releases
FDA Expands U.S. Age Indication for EVO ICL as Long-Term Safety Data Reinforces Market Shift Away From Laser Vision Correction
February 18, 2026
 · 
8 min read
Press Releases
Beta Bionics Announces Fourth Quarter and Full Year 2025 Financial Results and Introduces Annual Guidance for Full Year 2026
February 18, 2026
 · 
16 min read
Press Releases
Shield Therapeutics Announces FDA Approval of ACCRUFeR®, the First and Only Prescription Oral Iron Therapy Approved for Children Age 10 and Older
February 17, 2026
 · 
2 min read
Press Releases
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
February 17, 2026
 · 
2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
 · 
13 min read
Press Releases
Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
February 17, 2026
 · 
1 min read
Press Releases
OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma
February 17, 2026
 · 
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
 · 
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
 · 
32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
 · 
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
 · 
4 min read
Load More