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FDA

Ovarian cancer vaccine under research.
FDA
FDA Approves GSK’s PARP Inhibitor Zejula for New Ovarian Cancer Indication
Zejula, GlaxoSmithKline’s once-daily PARP inhibitor, won regulatory approval as a monotherapy maintenance treatment for women with advanced ovarian cancer whose disease is responsive to first-line platinum-based chemotherapy, regardless of biomarker status.
April 30, 2020
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3 min read
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Alex Keown
Tada Images / Shutterstock
FDA
FDA Approves New 6-Week Dosing for Keytruda for All Approved Adult Indications
The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
April 29, 2020
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2 min read
 · 
Alex Keown
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Neurocrine Biosciences Receives FDA Approval for Ongentys, Opts to Delay Launch
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
April 28, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: April 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
April 28, 2020
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6 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
April 27, 2020
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7 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
 · 
7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 23
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 23, 2020.
April 23, 2020
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5 min read
 · 
BioSpace Editorial Staff
Chronic lymphocytic leukemia
FDA
Imbruvica-Rituximab Combo Approved by FDA for Chronic Lymphocytic Leukemia
The FDA recently approved the combination of Imbruvica-Rituximab for treating chronic lymphocytic leukemia. Here’s everything you need to know.
April 22, 2020
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2 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
April 22, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
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
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
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