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Regulatory

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
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5 min read
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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
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3 min read
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BioSpace Editorial Staff
Policy
FDA to Investigate False Negative Reports Related to Abbott’s Rapid COVID-19 Test
Following a study that raises concerns about the accuracy of Abbott’s rapid COVID-19 test for detecting the virus, the U.S. Food and Drug Administration (FDA) announced it will investigate the claims found in a New York University-related study as the company updates its guidance on the ID NOW test.
May 15, 2020
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3 min read
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Alex Keown
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
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3 min read
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BioSpace Editorial Staff
Policy
Moderna’s Phase II-Ready COVID-19 Vaccine Candidate Snags Fast Track Designation
The designation will expedite regulatory review of the medication should it prove to be safe and effective.
May 13, 2020
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2 min read
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Alex Keown
Policy
Celgene CVR Holders Uncertain After FDA Refuses Review of BMS and bluebird’s Multiple Myeloma Therapy
This morning, the companies announced the regulatory agency issued a Refusal to File letter regarding the BLA for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pretreated relapsed and refractory multiple myeloma.
May 13, 2020
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2 min read
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Alex Keown
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
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3 min read
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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
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2 min read
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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
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3 min read
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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
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2 min read
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Alex Keown
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PRESS RELEASES
Press Releases
ImmunityBio Advances First-Line BCG Naive NMIBC Program with Enrollment Exceeding Expectations and Positive Interim Analysis for ANKTIVA® Plus BCG
January 16, 2026
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9 min read
Press Releases
CASI Pharmaceuticals Announces Approval of Clinical Trial Application by China NMPA for Phase 1 / 2 Study of CID-103 for Renal Allograft Antibody-Mediated Rejection (AMR)
January 16, 2026
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7 min read
Press Releases
Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation
January 16, 2026
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5 min read
Press Releases
Cardiac Biotech Solutions Activates China Production Pipeline for MyCardia AT and Moves into Final NMPA Submission Phase
January 16, 2026
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5 min read
Press Releases
AAVantgarde Completes Enrollment in LUCE-1 Phase 1/2 Clinical Trial of AAVB-081 for Usher Syndrome Type B-associated Retinitis Pigmentosa
January 16, 2026
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4 min read
Press Releases
Santhera Receives Swissmedic Approval of AGAMREE® (Vamorolone) for the Treatment of Duchenne Muscular Dystrophy
January 16, 2026
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4 min read
Press Releases
Press Release: Myqorzo and Redemplo approved in China
January 16, 2026
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8 min read
Press Releases
Hyundai Bioscience Confirms Entry into U.S. FDA Phase 2 Trials for Broad-Spectrum Antiviral ‘XAFTY’ Following 2026 Biotech Showcase Consensus
January 15, 2026
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3 min read
Press Releases
Adolore BioTherapeutics Announces FDA Orphan Drug Designation for its Kv7-activating rdHSV-CA8* Therapy in the Treatment of Erythromelalgia
January 15, 2026
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7 min read
Press Releases
VizMark Secures FDA 510k Clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging
January 15, 2026
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1 min read
Press Releases
FDA Approves Updated Label for Miach Orthopaedics’ BEAR® Implant to Include Significantly Lower Risk of Osteoarthritis
January 15, 2026
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5 min read
Press Releases
Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ
January 15, 2026
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8 min read
Press Releases
Femasys Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Price Requirement
January 15, 2026
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5 min read
Press Releases
Emergent BioSolutions Receives U.S. FDA Approval on Supplemental New Drug Application for NARCAN® Nasal Spray to be Packaged in a New Carrying Case, Making Life-Saving Naloxone More Accessible for Everyday Preparedness
January 15, 2026
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5 min read
Press Releases
NRx Pharmaceuticals (Nasdaq:NRXP) Announces 70,000 Patient Data on Real World Use of Ketamine for Treatment of Suicidal Depression to be Submitted to the FDA in Support of NRX-100 Approval
January 15, 2026
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6 min read
Press Releases
Routine FDA Inspection Reveals Zero Findings for Univo IRB
January 14, 2026
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1 min read
Press Releases
Vy Spine Announces FDA Clearance for VyBrate VBR System
January 14, 2026
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2 min read
Press Releases
Travere Therapeutics Announces FDA Extends Review of sNDA for FILSPARI® (sparsentan) in FSGS
January 14, 2026
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16 min read
Press Releases
FDA Files Rejoni’s Juveena® Hydrogel System PMA for the Prevention of Intrauterine Adhesions
January 14, 2026
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1 min read
Press Releases
U.S. FDA grants Ipsen’s IPN60340 (ICT01) Breakthrough Therapy Designation in first line unfit Acute Myeloid Leukemia
January 14, 2026
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8 min read
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