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Regulatory

Drug Development
Biopharma Update on the Novel Coronavirus: April 10
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.
April 10, 2020
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7 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.
April 9, 2020
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9 min read
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BioSpace Editorial Staff
FDA
FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations
“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
April 9, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 8, 2020.
April 8, 2020
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7 min read
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BioSpace Editorial Staff
Policy
Acceleron’s Clinical PAH Drug Wins Breakthrough Therapy Designation
The designation will allow the company to expedite the development and potential regulatory review of sotatercept.
April 8, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: April 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 7, 2020.
April 7, 2020
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6 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
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6 min read
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BioSpace Editorial Staff
Lenacapavir can be the first HIV capsid inhibitor.
Drug Development
Gilead Speeds Manufacture of Experimental COVID-19 Drug, Doesn’t Plan to Charge
One of the promising experimental drugs being tested to treat COVID-19, the disease caused by the novel coronavirus SARS-Cov2-, is Gilead Sciences’ remdesivir.
April 5, 2020
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4 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
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Mark Terry
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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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