SUBSCRIBE
SUBSCRIBE

Approvals

FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
 · 
3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
May 19, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
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
Load More
PRESS RELEASES
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
 · 
3 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
 · 
3 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
 · 
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
 · 
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
 · 
2 min read
Press Releases
/C O R R E C T I O N -- Accord BioPharma/
February 17, 2026
 · 
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
 · 
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
 · 
32 min read
Press Releases
FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim)
February 17, 2026
 · 
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
 · 
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
 · 
9 min read
Press Releases
InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device
February 13, 2026
 · 
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
 · 
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
 · 
5 min read
Press Releases
FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
February 12, 2026
 · 
3 min read
Press Releases
Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease
February 12, 2026
 · 
3 min read
Press Releases
U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer
February 12, 2026
 · 
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
 · 
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
 · 
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
 · 
5 min read
Load More