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Approvals

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FDA
Tabrecta: FDA Gives Novartis Approval for First-Ever Therapy for NSCLC Tumors with METex14
Developed by Novartis, the drug, Tabrecta, is designed for a type of NSCLC that has spread to other parts of the body and cannot be removed by surgery.
May 6, 2020
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4 min read
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Gail Dutton
Courtesy of Alexanderstock23/Shutterstock
FDA
FDA Approves AstraZeneca’s Farxiga for Heart Failure in Adults with Reduced Ejection Fraction
The drug can potentially reduce the risk of cardiovascular death and hospitalization for heart failure.
May 6, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: May 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 6, 2020.
May 6, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 5, 2020.
May 5, 2020
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6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 4, 2020.
May 4, 2020
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5 min read
 · 
BioSpace Editorial Staff
FDA
Roche Wins Emergency Approval for its COVID-19 Antibody Test
The U.S. Food and Drug Administration green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus and developed antibodies to the disease.
May 4, 2020
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2 min read
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Alex Keown
FDA
FDA Grants Gilead’s Remdesivir Emergency Use Authorization for COVID-19
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
May 1, 2020
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3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.
May 1, 2020
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5 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 30, 2020.
April 30, 2020
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5 min read
 · 
BioSpace Editorial Staff
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
 · 
Alex Keown
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PRESS RELEASES
FDA
Allergy Therapeutics announces FDA clearance of IND application for novel peanut allergy vaccine candidate VLP Peanut
January 26, 2022
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5 min read
Drug Development
Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia
January 25, 2022
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5 min read
FDA
Maxim Biomedical Inc. Receives EUA for New ClearDetect™ COVID-19 Antigen Home Test
January 25, 2022
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3 min read
FDA
Paracrine Receives FDA Approval to Launch a U.S. Pivotal Trial in Patients With Hand Dysfunction Due to Diffuse Cutaneous Scleroderma
January 25, 2022
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4 min read
FDA
Catalyst Biosciences Receives Rare Pediatric Disease Designation for CB 4332 for the Treatment of CFI Deficiency
January 25, 2022
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3 min read
FDA
FDA Clears MindMed IND for MM-120 in Treatment of Generalized Anxiety Disorder
January 25, 2022
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5 min read
FDA
Senhwa’s Pidnarulex Receives US FDA Fast Track Designation for the Treatment of Solid Tumors with BRCA1/2, PALB2 and other HR Gene Mutations
January 25, 2022
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3 min read
FDA
Nevro Responds to Competitor’s Announcement of FDA Approval for Painful Diabetic Neuropathy
January 25, 2022
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8 min read
Drug Development
Nanoscope Therapeutics Announces FDA Clearance of IND for MCO-010 Gene Therapy in Stargardt Macular Degeneration Patients
January 25, 2022
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2 min read
FDA
Imara Announces FDA Clearance of Investigational New Drug Application (IND) for Tovinontrine (IMR-687) for Heart Failure with Preserved Ejection Fraction (HFpEF)
January 25, 2022
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6 min read
Drug Development
SwanBio Therapeutics Announces FDA Investigational New Drug Clearance for First AAV-Based Gene Therapy for the Treatment of Adrenomyeloneuropathy
January 25, 2022
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3 min read
FDA
Mammoth Biosciences Receives FDA Emergency Use Authorization for First CRISPR-based High-Throughput COVID-19 Test
January 24, 2022
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2 min read
FDA
Ranok Therapeutics Announces U.S. FDA Clearance to Proceed With Its First-in-Human Trial of RNK05047 in Patients With Advanced Solid Tumor Cancers and Lymphomas (CHAMP-1)
January 24, 2022
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2 min read
Drug Development
Lyell Immunopharma Announces FDA Clearance of IND for LYL132
January 24, 2022
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7 min read
Business
Eplontersen granted Orphan Drug Designation in the US for transthyretin amyloidosis
January 24, 2022
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5 min read
FDA
Ionis announces eplontersen receives orphan drug designation from U.S. FDA
January 24, 2022
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5 min read
FDA
Karyopharm Receives Orphan Drug Designation from FDA for Eltanexor for the Treatment of Myelodysplastic Syndromes
January 24, 2022
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8 min read
FDA
Lantern Pharma Receives Rare Pediatric Disease and Orpan Drug Designations for LP-184 for the Treatment of Atypical Teratoid Rhabdoid Tumor (ATRT)
January 24, 2022
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7 min read
FDA
Tango Therapeutics Announces Clearance of TNG908 IND by FDA and Recent Pipeline Progress Updates
January 24, 2022
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8 min read
FDA
SQZ Biotechnologies Announces FDA Clearance of Investigational New Drug (IND) Application for SQZ-eAPC-HPV, a Novel mRNA-based Cell Therapy for the Treatment of HPV16 Positive Solid Tumors
January 24, 2022
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7 min read
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