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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: June 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
June 18, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Second Biomarker-Specific Indication for Merck’s Keytruda
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
June 17, 2020
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2 min read
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Alex Keown
Uplizna got green signal from FDA
FDA
FDA Greenlights Two Novartis Drugs, Including First for Adult-Onset Still’s Disease
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
June 17, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
June 16, 2020
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5 min read
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BioSpace Editorial Staff
REC Stock Footage / Shutterstock
FDA
FDA Approves Akili’s Therapeutic Video Game for ADHD
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
June 16, 2020
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3 min read
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Mark Terry
FDA
Jazz Pharma Gets Approval for Zepzelca in the U.S. for Aggressive Lung Cancer
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
June 16, 2020
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3 min read
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Mark Terry
IgorGolovniov/Shutterstock
FDA
FDA Cancels Emergency Use Authorization of Hydroxychloroquine for COVID-19
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
June 15, 2020
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3 min read
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Mark Terry
FDA
ViiV’s Tivicay Approved for Children as Young as 4 Weeks with HIV
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.
June 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
June 15, 2020
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3 min read
 · 
BioSpace Editorial Staff
Uplizna got green signal from FDA
FDA
FDA Greenlight’s Viela Bio’s Uplizna for Rare Neuroinflammatory Autoimmune Disorder
The FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive. About 80% of all NMOSD patients test positive for anti-AQP4 antibodies.
June 12, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
FDA
Myrtelle Receives FDA Fast Track, Rare Pediatric Disease, and Orphan Drug Designations for its Proprietary Gene Therapy for the Treatment of Canavan Disease
March 15, 2022
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6 min read
FDA
FDA Grants Orphan Drug Designation to SBT101, the First Investigational AAV-Based Gene Therapy for Adrenomyeloneuropathy (AMN)
March 15, 2022
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3 min read
Drug Development
Kairos Pharma Receives FDA Approval of Investigational New Drug (IND) Application for Its Phase 1 Clinical Trial of KROS 201 for the Treatment of Glioblastoma; Announces New Patent for KROS 401
March 14, 2022
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5 min read
FDA
Fresenius Kabi Receives U.S. Food and Drug Administration 510(k) Clearance for Wireless Agilia® Connect Infusion System with Vigilant® Software Suite-Vigilant® Master Med Technology
March 14, 2022
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3 min read
FDA
Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease
March 14, 2022
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13 min read
FDA
Shoulder Innovations Announces FDA Clearance of New InSet™ Stemless Humeral Implant
March 14, 2022
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3 min read
FDA
FDA Approves LYNPARZA® (olaparib) as Adjuvant Treatment for Patients With Germline BRCA-Mutated (gBRCAm), HER2-Negative High-Risk Early Breast Cancer Who Have Been Treated With Neoadjuvant or Adjuvant Chemotherapy
March 11, 2022
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24 min read
FDA
LYNPARZA® (olaparib) approved in the US as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer
March 11, 2022
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25 min read
FDA
Hoth Therapeutics Announces Orphan Drug Designation Granted to Cancer Therapeutic HT-KIT to Treat Mastocytosis
March 11, 2022
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5 min read
FDA
S.M.A.R.T. RADIANZ™ Vascular Stent System Approved for Transradial Use in the U.S.
March 10, 2022
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3 min read
FDA
TRACON Pharmaceuticals Announces FDA Approval of Amended ENVASARC Protocol
March 10, 2022
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6 min read
FDA
INSIGHTEC RECEIVES FDA IDE APPROVAL AND “BREAKTHROUGH” DESIGNATION FOR NSCLC BRAIN METS STUDY AND IDE APPROVAL FOR LIQUID BIOPSY STUDY
March 9, 2022
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4 min read
FDA
Genmab Announces U.S. Food and Drug Administration Granted Orphan-Drug Designation to Epcoritamab (DuoBody®-CD3xCD20) in Follicular Lymphoma
March 8, 2022
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7 min read
FDA
Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System
March 7, 2022
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4 min read
FDA
Harpoon Therapeutics Granted Orphan Drug Designation for HPN328 for Treatment of Small Cell Lung Cancer
March 7, 2022
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6 min read
FDA
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer
March 4, 2022
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26 min read
FDA
I-Mab Receives FDA Orphan Drug Designation for its Novel Claudin 18.2 x 4-1BB Bispecific Antibody TJ-CD4B for the Treatment of Gastric Cancer
March 3, 2022
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6 min read
FDA
Kashiv Biosciences Receives Approval for Its First Biosimilar RELEUKOTM (filgrastim-ayow)
March 2, 2022
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4 min read
FDA
FDA Approves Kaléo’s 10 mg Naloxone Auto-Injector for the Treatment of Known or Potential Exposure to Ultra-Potent Weaponized Opioids
March 2, 2022
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5 min read
FDA
Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence
March 2, 2022
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5 min read
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