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Approvals

FDA
FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
August 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
August 17, 2020
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2 min read
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BioSpace Editorial Staff
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
 · 
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
 · 
BioSpace Editorial Staff
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PRESS RELEASES
FDA
Sol-Gel Technologies and Galderma Announce FDA Approval of EPSOLAY®
April 25, 2022
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10 min read
FDA
Quanterix Granted Breakthrough Device Designation from U.S. FDA for NfL Test for Multiple Sclerosis
April 22, 2022
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4 min read
FDA
FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial
April 21, 2022
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3 min read
FDA
Breckenridge Announces Approval of its ANDA for Miglustat Capsules (generic for Zavesca®)
April 21, 2022
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1 min read
FDA
Tvardi Therapeutics’ TTI-101 Receives Orphan Drug Designation for Hepatocellular Carcinoma
April 21, 2022
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2 min read
FDA
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for Prevention of Multiple Life-Threatening Infections from Six Viruses in Allogeneic Hematopoietic Cell Transplant Patients
April 20, 2022
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7 min read
FDA
Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland
April 19, 2022
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6 min read
FDA
Virtual Incision Announces Approval to Complete Clinical Study Enrollment for its MIRA® Platform
April 19, 2022
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4 min read
FDA
Aytu BioPharma Announces Fast Track Designation Granted to AR101 for the Treatment of Vascular Ehlers-Danlos Syndrome
April 19, 2022
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4 min read
FDA
Adicet Bio Receives FDA Fast Track Designation for Lead Candidate ADI-001
April 19, 2022
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4 min read
FDA
FDA Approves Alymsys® (bevacizumab-maly), a Biosimilar of Bevacizumab by Amneal Pharmaceuticals, Inc., developed by mAbxience
April 18, 2022
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1 min read
Business
Junshi Biosciences and Coherus Announce PD-1 Inhibitor Toripalimab Granted Orphan Drug Designation for Small Cell Lung Cancer in the United States
April 14, 2022
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11 min read
FDA
Biohaven Announces Expanded Patient Access to Nurtec® ODT (rimegepant), Achieving Best-in-Class Commercial Insurance Coverage and Label Update
April 14, 2022
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8 min read
FDA
Amneal Achieves Second U.S. Biosimilars Approval with ALYMSYS® (bevacizumab-maly)
April 13, 2022
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7 min read
FDA
Biofrontera Inc. Announces FDA Approval of Biofrontera Pharma GmbH as a Contract Laboratory for Ameluz®
April 13, 2022
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4 min read
FDA
Pear Therapeutics Receives Safer Technologies Program (STeP) Designation from FDA for Product Candidate to Treat Acute and Chronic Pain
April 13, 2022
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7 min read
FDA
BOTOX® Cosmetic (onabotulinumtoxinA) Celebrates 20 Years Since First U.S. FDA Approval
April 13, 2022
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8 min read
FDA
Blue Earth Therapeutics Announces U.S. FDA Clearance for Investigational New Drug (IND) Application for 177Lu-rhPSMA-10.1 for Treatment of Prostate Cancer
April 12, 2022
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5 min read
FDA
FDA Clears Four New Coronary Micro Support Catheters
April 12, 2022
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2 min read
FDA
Recursion is Granted Fast Track Designation for REC-4881 for the Potential Treatment of Familial Adenomatous Polyposis
April 11, 2022
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5 min read
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