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Regulatory

Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
July 20, 2020
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2 min read
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BioSpace Editorial Staff
Policy
FDA Action Alert: Jazz, ANI and Ultragenyx
Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.
July 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
July 16, 2020
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5 min read
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BioSpace Editorial Staff
Policy
FDA Panel Votes 8-7 in Favor of Mallinckrodt’s HRS-1 Drug
Shares of Mallinckrodt climbed after the company announced the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1.
July 16, 2020
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2 min read
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Alex Keown
It's a yes for GSK’s multiple myeloma drug belanta
Policy
FDA Advisory Committee Votes 12-0 to Recommend GSK’s Multiple Myeloma Drug Belantamab Mafodotin
“We are pleased the committee recognized the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” said Axel Hoos, senior vice president and heat of Oncology R&D for GSK.
July 15, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
July 14, 2020
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5 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: July 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 13, 2020.
July 13, 2020
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3 min read
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BioSpace Editorial Staff
Policy
BioNTech, Pfizer Snag Fast Track Designation for Two COVID-19 Vaccine Candidates
The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
July 13, 2020
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2 min read
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Alex Keown
Policy
Good, But Not Good Enough: FDA Rejects Merck-Eisai Combo for Liver Cancer
The U.S. Food and Drug Administration issued a Complete Response Letter to Merck and Eisai over their Lenvima and Keytruda combination for first-line treatment of unresectable hepatocellular carcinoma (HCC).
July 9, 2020
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3 min read
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Mark Terry
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PRESS RELEASES
Press Releases
FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
February 18, 2026
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8 min read
Press Releases
FDA Grants PMA Approval to LimiFlex(TM) Dynamic Sagittal Tether
February 18, 2026
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3 min read
Press Releases
ImmunityBio Receives Authorization from the European Commission for ANKTIVA® with BCG for Non-Muscle Invasive Bladder Cancer Carcinoma in Situ, Expanding Global Access to 33 Countries
February 18, 2026
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14 min read
Press Releases
FDA Approval Granted for Commercial Manufacturing at Rezon Bio’s Warsaw-Duchnice Facility
February 18, 2026
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3 min read
Press Releases
Maestro MEA Platform Powers First Stem Cell Cardiac Safety Assay in FDA ISTAND Program
February 18, 2026
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3 min read
Press Releases
Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM)
February 18, 2026
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3 min read
Press Releases
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
February 18, 2026
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2 min read
Press Releases
Klotho Neurosciences Receives Patent Claims in Australia for Composition and Use of Human Secreted Klotho Protein (“s-KL”) Isoform of the Human Klotho Gene Sequence
February 18, 2026
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4 min read
Press Releases
Pluri Secures Global IP Position with China Patent Grant for Large-Scale Immune Cell Expansion, Complementing Prior U.S. Patent
February 18, 2026
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6 min read
Press Releases
Vietnam Approves Biomerica’s EZ Detect™ for Nationwide Distribution
February 18, 2026
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8 min read
Press Releases
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
February 18, 2026
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26 min read
Press Releases
Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance
February 18, 2026
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4 min read
Press Releases
Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB)
February 18, 2026
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8 min read
Press Releases
Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission
February 18, 2026
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4 min read
Press Releases
CervoMed’s neflamapimod elected for inclusion in UK EXPERTS-ALS platform designed to prioritize promising treatments for Amyotrophic Lateral Sclerosis
February 18, 2026
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10 min read
Press Releases
Helsinn announces European Commission approval of AKYNZEO® Oral Suspension
February 18, 2026
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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
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8 min read
Press Releases
Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging
February 18, 2026
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10 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
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2 min read
Press Releases
Health Canada Approves KEYTRUDA SC™, a subcutaneous formulation of pembrolizumab across multiple cancer indications
February 17, 2026
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7 min read
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