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FDA

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Gets FDA Approval for $259K Per Year CF Drug
July 6, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs Amgen’s Repatha, But With Strings Attached
June 11, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Genentech Wins Breakthrough Nod From FDA for Systemic Sclerosis Treatment
June 10, 2015
 · 
4 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Advisors Back Regeneron, Sanofi’s New Heart Drug With Limits
June 10, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Designation to Genzyme’s Experimental ASMD Treatment
June 4, 2015
 · 
2 min read
Gilead’s Hep B Trial Failure Will Inspire M&A Activity, Say Analysts
FDA
Rapamune, Pfizer’s Branding-Troubled Drug, Gets FDA Approval for Rare Lung Disease
May 29, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Drug Development
Heart-Stopping Morning Leads to Vertex Rise As FDA News Sees Positives
May 8, 2015
 · 
3 min read
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
 · 
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
 · 
2 min read
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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
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