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Regulatory

Policy
Biopharma Update on the Novel Coronavirus: July 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
July 23, 2020
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4 min read
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Editorial Staff
FDA
Jazz Pharma Wins FDA Approval for Lower-Sodium Narcolepsy Treatment
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
July 22, 2020
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2 min read
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Alex Keown
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
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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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