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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: August 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
August 13, 2020
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3 min read
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BioSpace Editorial Staff
Duchenne Muscular Dystrophy
FDA
FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
August 13, 2020
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3 min read
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Mark Terry
Maxigesic IV on hold until FDA gets clarity on the
FDA
FDA Approves Trevena’s IV Opioid Olinvyk for Short-Term Acute Pain Management
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
August 13, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
August 11, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Genentech Joins Biogen and Novartis in the Spinal Muscular Atrophy Market
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
August 10, 2020
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4 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
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5 min read
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BioSpace Editorial Staff
Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
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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
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
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
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
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13 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
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
InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device
February 13, 2026
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2 min read
Press Releases
Emergent BioSolutions Receives U.S. FDA Approval of Supplemental New Drug Application (sNDA) for NARCAN® Nasal Spray Multipacks
February 12, 2026
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4 min read
Press Releases
KBroVet® (potassium bromide chewable tablets) Becomes First FDA Fully Approved Pharmaceutical For The Control of Seizures Associated with Idiopathic Epilepsy in Dogs
February 12, 2026
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5 min read
Press Releases
FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
February 12, 2026
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3 min read
Press Releases
Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease
February 12, 2026
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3 min read
Press Releases
U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer
February 12, 2026
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13 min read
Press Releases
KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second or Third Line Treatment
February 11, 2026
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19 min read
Press Releases
Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC)
February 11, 2026
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3 min read
Press Releases
Trinity Biotech Secures Regulatory Approval for Commencement of Upstream Manufacturing Activities of Uni-Gold™ HIV Rapid Test Under Its Offshored and Outsourced Model, Supporting Financial Performance Transformation
February 11, 2026
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5 min read
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