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Regulatory

Policy
Biopharma Update on the Novel Coronavirus: August 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
August 11, 2020
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5 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 10, 2020.
August 10, 2020
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2 min read
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BioSpace Editorial Staff
FDA
Genentech Joins Biogen and Novartis in the Spinal Muscular Atrophy Market
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
August 10, 2020
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4 min read
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Mark Terry
Policy
FDA Accepts BLA for Biogen’s Alzheimer’s Drug, Grants Priority Review
The FDA set a PDUFA target date of March 7, 2021 for aducanumab, Biogen said.
August 7, 2020
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2 min read
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Alex Keown
Policy
FDA Action Alert: Fennec, Gilead/Kite, Deciphera and Jazz/PharmaMar
Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.
August 6, 2020
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4 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
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5 min read
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BioSpace Editorial Staff
Policy
FDA Issues CRL for DBV Technologies’ Viaskin Peanut Allergy Patch
In its CRL, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications.
August 4, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
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3 min read
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BioSpace Editorial Staff
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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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