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FDA

FDA
Novartis Wins Approval for First-of-its-Kind Breast Cancer Treatment
The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
May 28, 2019
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2 min read
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Alex Keown
FDA
Incyte’s Jakafi Snags FDA Approval for Treatment of Steroid-Refractory Acute GVHD
The approval of Jakafi marks the first approved treatment for this indication in the United States.
May 28, 2019
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2 min read
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Alex Keown
lucarista/Shutterstock
FDA
Novartis’ SMA Gene Therapy Treatment Approved by FDA, Priced at $2.125 Million
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.
May 24, 2019
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4 min read
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Alex Keown
FDA
Novocure Wins FDA Approval for First Mesothelioma Treatment in 15 Years
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
May 24, 2019
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2 min read
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Alex Keown
FDA
Australia’s Mayne Pharma Receives FDA Nod for Adolescent Plaque Psoriasis Treatment
Sorilux was approved for the treatment of patients age 12 and up.
May 22, 2019
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2 min read
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Alex Keown
StockStudio/Compressed
FDA
FDA Approves Pfizer’s Treatment for Fatal, Rare Heart Disease
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
May 21, 2019
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3 min read
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Alex Keown
FDA
Takeda Wins FDA Approval for Pediatric Use of Short Bowel Syndrome Treatment
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
May 20, 2019
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2 min read
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Alex Keown
FDA
UCB Wins FDA Approval for Epilepsy Treatment Acquired in $370 Million Deal
NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
May 20, 2019
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2 min read
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Alex Keown
StockStudio/Compressed
FDA
FDA Approves First VTE Treatment for Pediatric Patients
Pfizer’s Fragmin was approved to reduce the recurrence of VTE in patients one month of age or older.
May 17, 2019
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2 min read
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Alex Keown
FDA
FDA Approves Combination Treatment for CLL and SLL
The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
May 16, 2019
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2 min read
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Alex Keown
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PRESS RELEASES
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
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3 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
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3 min read
Press Releases
Maestro MEA Platform Powers First Stem Cell Cardiac Safety Assay in FDA ISTAND Program
February 18, 2026
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3 min read
Press Releases
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
February 18, 2026
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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
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26 min read
Press Releases
Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance
February 18, 2026
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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
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8 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
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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
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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
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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
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2 min read
Press Releases
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
February 17, 2026
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2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
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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
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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
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