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Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
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4 min read
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BioSpace Editorial Staff
Stanford serology test is finally here.
FDA
Stanford Serology Test: Stanford Joins List of Organizations Offering COVID-19 Antibody Testing
The Stanford serology test provides results in two to three days and Stanford Health Care can test 500 samples per day. Know what more it has to offer.
April 13, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
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9 min read
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BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
FDA
Black Diamond Therapeutics Announces FDA Allowance of IND Application for BDTX-1535, A MasterKey Inhibitor of EGFR for the Treatment of Gliobastoma and Non-Small Cell Lung Cancer
January 11, 2022
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5 min read
FDA
Jeffrey D. Horn, M.D. Announces First FDA-Approved Eye Drop to Treat Age-Related Blurry Vision Now Available at Vision for Life
January 11, 2022
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2 min read
FDA
COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis
January 10, 2022
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3 min read
FDA
BD Introduces Smart Connected Robotics to Automate Microbial Identification
January 7, 2022
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4 min read
FDA
Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17
January 6, 2022
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11 min read
FDA
FDA Grants Breakthrough Device Designation to JelikaLite
January 6, 2022
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4 min read
FDA
Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study
January 5, 2022
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3 min read
FDA
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for the Treatment of Adenovirus (AdV) Infections in Adults and Children Post-Allogeneic Stem Cell Transplantation
January 5, 2022
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9 min read
FDA
Abbott’s Proclaim™ XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S.
January 4, 2022
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4 min read
FDA
Adverum Biotechnologies Granted Orphan Drug Designation by FDA for Gene Therapy Candidate in Preclinical Development for the Treatment of Blue Cone Monochromacy
January 4, 2022
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3 min read
FDA
ANANDA Scientific Announces FDA approval of the IND for the Clinical Trial on the Treatment of Opioid Use Disorder (OUD)
January 4, 2022
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2 min read
FDA
FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
January 4, 2022
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4 min read
FDA
FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1
January 3, 2022
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6 min read
FDA
U.S. Food and Drug Administration Approves Immix Biopharma Rare Pediatric Disease Designation for IMX-110 as a Treatment for Life-Threatening Pediatric Cancer in Children
January 3, 2022
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5 min read
FDA
Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome
December 30, 2021
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15 min read
FDA
Paragon 28, Inc. R3ACT™ Stabilization System Cleared by FDA
December 29, 2021
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2 min read
FDA
LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis
December 28, 2021
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11 min read
FDA
Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System
December 27, 2021
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7 min read
FDA
Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML
December 27, 2021
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5 min read
FDA
FDA Authorizes Further NurOwn® Dosing Under Expanded Access Program
December 27, 2021
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7 min read
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