SUBSCRIBE
SUBSCRIBE

Approvals

FDA
FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
May 19, 2020
 · 
2 min read
 · 
Mark Terry
FDA
Clovis Oncology’s PARP Inhibitor Rubraca Gets Greenlight from FDA in Prostate Cancer
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
May 18, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
May 18, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
May 15, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
May 14, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
May 13, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Report: NDA, BLA Approvals by the FDA Fell 16% in 2019
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
May 12, 2020
 · 
2 min read
 · 
Krystle Vermes
Drug Development
Biopharma Update on the Novel Coronavirus: May 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
May 12, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
FDA
Abbott Earns Emergency Use Authorization for Another COVID-19 Antibody Test
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
May 11, 2020
 · 
2 min read
 · 
Alex Keown
TARPEYO is the first FDA-approved drug for immunog
FDA
AstraZeneca and Merck’s Lynparza Approved For Ovarian Cancer Just a Week After GSK’s Zejula
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
May 11, 2020
 · 
3 min read
 · 
Mark Terry
Load More
PRESS RELEASES
Press Releases
Vanda Pharmaceuticals Announces FDA Approval of NEREUS™ (tradipitant) for the Prevention of Vomiting Induced by Motion: A Historic Scientific Milestone in the Prevention of Motion Sickness
December 30, 2025
 · 
9 min read
Press Releases
Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction
December 29, 2025
 · 
7 min read
Press Releases
China’s First Domestic Anti-CTLA-4 Monoclonal Antibody, Innovent’s TABOSUN® (Ipilimumab N01 Injection) Received NMPA Approval
December 25, 2025
 · 
11 min read
Press Releases
FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA
December 25, 2025
 · 
17 min read
Press Releases
U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia
December 24, 2025
 · 
15 min read
Press Releases
FDA Approves Edwards Lifesciences’ SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
December 24, 2025
 · 
4 min read
Press Releases
Zai Lab Announces Approval of COBENFY (xanomeline and trospium chloride) in China, a First-in-Class Therapy for Schizophrenia
December 24, 2025
 · 
7 min read
Press Releases
Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
December 24, 2025
 · 
9 min read
Press Releases
Health Canada Approves TEVIMBRA® (tislelizumab for injection) in Combination with Gemcitabine and Cisplatin for the First-Line Treatment of Adult Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma
December 24, 2025
 · 
10 min read
Press Releases
InnoCare Announces NMPA Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Cutaneous Lupus Erythematosus
December 23, 2025
 · 
1 min read
Press Releases
IRLAB Receives Approval for a Phase Ib Study with IRL757 in Parkinson’s Disease
December 23, 2025
 · 
4 min read
Press Releases
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma
December 23, 2025
 · 
23 min read
Press Releases
Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma
December 23, 2025
 · 
14 min read
Press Releases
GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea
December 23, 2025
 · 
3 min read
Press Releases
Samsung Bioepis Announces Approval of Ustekinumab Biosimilar in Japan
December 23, 2025
 · 
2 min read
Press Releases
FDA approves Novo Nordisk’s Wegovy® pill, the first and only oral GLP-1 for weight loss in adults
December 23, 2025
 · 
14 min read
Press Releases
Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management
December 23, 2025
 · 
4 min read
Press Releases
Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA®
December 23, 2025
 · 
6 min read
Press Releases
RevBio® Receives Approval from FDA to Start a Dental Clinical Trial for its Regenerative Bone Glue
December 23, 2025
 · 
3 min read
Press Releases
Abbott’s Volt™ Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation
December 23, 2025
 · 
5 min read
Load More