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Policy
Biopharma Update on the Novel Coronavirus: November 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 3, 2020.
November 3, 2020
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5 min read
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BioSpace Editorial Staff
EYSUVIS become the first FDA approved treatment fo
FDA
Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment EYSUVIS
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease. Know more about how it got approval and the complete development timeline here.
October 27, 2020
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3 min read
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Kate Goodwin
Policy
Biopharma Update on the Novel Coronavirus: October 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
October 27, 2020
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4 min read
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BioSpace Editorial Staff
Courtesy Taljat David/Getty Images
FDA
Novartis Sees Glimmer of Hope for Branaplam in Huntington’s Disease
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
October 23, 2020
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2 min read
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Heather McKenzie
Sonis Photography / Shutterstock
FDA
FDA Grants Full Approval to Remdesivir for COVID-19
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
October 22, 2020
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3 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: October 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
October 20, 2020
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5 min read
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BioSpace Editorial Staff
Courtesy of Taljat David/Shutterstock
FDA
Roche’s Venclexta Granted Full Approval Under Project Orbis and Real-Time Review
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
October 19, 2020
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3 min read
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Mark Terry
FDA
FDA Action Alert: Zosano, Spectrum, Regeneron, Kala and Merck
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
October 16, 2020
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5 min read
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Mark Terry
Inmazeb is the world's first treatment for Ebola.
FDA
Regeneron’s Inmazeb Becomes First Ebola Treatment Approved by FDA
Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
October 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: October 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
October 13, 2020
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4 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
FDA
TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-101 for the Treatment of Hematologic Malignancies
May 31, 2022
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6 min read
FDA
FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
May 27, 2022
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13 min read
FDA
U.S. Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma
May 27, 2022
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29 min read
Drug Development
Instil Bio Announces IND Clearance of First CoStAR-TIL program, ITIL-306, Designed to Enhance Activity in the Tumor Microenvironment
May 27, 2022
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7 min read
FDA
Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA™ (pegfilgrastim-pbbk)
May 27, 2022
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9 min read
FDA
FDA Approves RADICAVA ORS® (edaravone) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS) by Mitsubishi Tanabe
May 26, 2022
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2 min read
FDA
Revolutionary Wearable Ultrasound Device Gains FDA Approval
May 26, 2022
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3 min read
FDA
PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR OMEPRAZOLE MAGNESIUM DELAYED-RELEASE MINI CAPSULES
May 26, 2022
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5 min read
FDA
Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® Cosmetic Technology in Dermal Resurfacing Procedures
May 26, 2022
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5 min read
Drug Development
US FDA Clears IND for Cynata’s Phase 2 Clinical Trial of CYP-001 in GvHD
May 26, 2022
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5 min read
Business
Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics
May 26, 2022
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5 min read
FDA
Servier Announces FDA Approval of TIBSOVO® (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
May 25, 2022
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18 min read
FDA
ŌNŌCOR Receives FDA Clearance for Novel Endovascular Retrieval Technology
May 25, 2022
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2 min read
FDA
Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions
May 25, 2022
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7 min read
FDA
FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm
May 24, 2022
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6 min read
FDA
Noveome Biotherapeutics, Inc. Receives Rare Pediatric Disease Designation and Orphan Drug Designation for the Treatment of Necrotizing Enterocolitis in Neonates
May 24, 2022
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2 min read
FDA
ENB Therapeutics Announces Orphan Drug Designation Granted by FDA for ENB-003 for the Treatment of Pancreatic Cancer
May 24, 2022
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5 min read
Business
Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format
May 24, 2022
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2 min read
FDA
inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION
May 24, 2022
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2 min read
FDA
Amphastar Receives FDA Approval for Regadenoson
May 24, 2022
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5 min read
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