Recent blog posts
FDA Grants Authorization for Biogen's TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Linked to ACTEMRA®
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FDA Grants Authorization for Biogen's TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Linked to ACTEMRA®
12 October 2023
Biogen Inc. disclosed that the U.S. FDA provided their endorsement for TOFIDENCE (tocilizumab-bavi) in an intravenous format, a biosimilar monoclonal antibody that references ACTEMRA.
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AbbVie shares findings from its Phase 3 trial involving Venetoclax for individuals with Multiple Myeloma
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AbbVie shares findings from its Phase 3 trial involving Venetoclax for individuals with Multiple Myeloma
12 October 2023
AbbVie shared Phase 3 CANOVA trial results for the VenDex combo in treating relapsed or resistant multiple myeloma in patients with two or more prior treatments.
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JCR Pharmaceuticals Reveals Findings from Phase I/II Research of JR-171 in people with Mucopolysaccharidosis Type I
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JCR Pharmaceuticals Reveals Findings from Phase I/II Research of JR-171 in people with Mucopolysaccharidosis Type I
12 October 2023
JCR Pharmaceuticals Co., Ltd. has disclosed critical findings from the midway 52-week data of its global research phase I/II involving JR-171 (lepunafusp alfa) in patients diagnosed with mucopolysaccharidosis type I.
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Geron Reports Validation by EMA of Marketing Approval Submission for Imetelstat
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Geron Reports Validation by EMA of Marketing Approval Submission for Imetelstat
11 October 2023
Geron Corporation declared that the Marketing Authorization Application concerning imetelstat-a novel experimental telomerase inhibitor-has been accepted and validated by the EMA.
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FDA approves priority review of Odronextamab BLA for relapsed/refractory follicular and diffuse large B-cell lymphoma
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FDA approves priority review of Odronextamab BLA for relapsed/refractory follicular and diffuse large B-cell lymphoma
11 October 2023
FDA accepts Priority Review of Odronextamab BLA for Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma.
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IMUNON Announces Data from Phase 1/2 OVATION 2 Trial for Late-Stage Ovarian Cancer
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IMUNON Announces Data from Phase 1/2 OVATION 2 Trial for Late-Stage Ovarian Cancer
11 October 2023
IMUNON released preliminary PFS and OS statistics related to IMNN-001 from its Phase 1/2 OVATION 2 Investigation.
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Structure Therapeutics reports outcomes from the Phase 1b clinical study of GSBR-1290
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Structure Therapeutics reports outcomes from the Phase 1b clinical study of GSBR-1290
11 October 2023
Structure Therapeutics has revealed encouraging results from its Phase 1b incremental dose study of its exclusive oral GLP-1 receptor agonist, GSBR-1290, in overweight or obese individuals.
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Amicus Therapeutics Declares FDA Sanction and Introduction of Novel Therapy for Pompe Disease
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Amicus Therapeutics Declares FDA Sanction and Introduction of Novel Therapy for Pompe Disease
10 October 2023
Amicus Therapeutics has confirmed that the U.S. FDA has given the green light to Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules.
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IASO Bio showcases Updated Long-Term Follow-Up information for BCMA CAR-T FUCASO®
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IASO Bio showcases Updated Long-Term Follow-Up information for BCMA CAR-T FUCASO®
10 October 2023
These studies focused on the outcomes of the Phase 1b/2 study carried out on patients who had relapsed/refractory multiple myeloma and were undergoing treatment with Equecabtagene Autoleucel.
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Mabwell Discloses Initial Patient Treatment in Phase Ib/II Study for Nectin-4 Focused ADC coupled with PD-1 Inhibitor
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Mabwell Discloses Initial Patient Treatment in Phase Ib/II Study for Nectin-4 Focused ADC coupled with PD-1 Inhibitor
10 October 2023
Mabwell announced the initiation of a Phase Ib/II trial with the first patient dosage. The study uses their novel Nectin-4 ADC (9MW2821) in conjunction with a PD-1 inhibitor for advanced or metastatic urothelial carcinoma.
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ImmunoGenesis administers first patient in the Phase 1a/1b clinical study of IMGS-001 for advanced solid tumors
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ImmunoGenesis administers first patient in the Phase 1a/1b clinical study of IMGS-001 for advanced solid tumors
10 October 2023
ImmunoGenesis announced the first patient treatment in their Phase 1a/1b trial using IMGS-001 at The University of Texas MD Anderson Cancer Center.
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The FDA grants Merck accelerated consideration for their new BLA for the Activin Signaling Inhibitor, Sotatercept
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The FDA grants Merck accelerated consideration for their new BLA for the Activin Signaling Inhibitor, Sotatercept
10 October 2023
Merck has declared that a fresh BLA for sotatercept has been approved for accelerated assessment by the U.S. FDA.
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