Recent blog posts
Aldeyra Therapeutics Gets Full Feedback Note from U.S. FDA on New Eye Dryness Medication Submission, Reproxalap
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Aldeyra Therapeutics Gets Full Feedback Note from U.S. FDA on New Eye Dryness Medication Submission, Reproxalap
7 December 2023
Aldeyra Therapeutics, Inc. has disclosed that it has received a Complete Response Letter from the FDA regarding the New Drug Application of reproxalap.
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Neumora Therapeutics Reveals FDA Approval for NMRA-266 Investigational New Drug and Commences Phase 1 Human Trials
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Neumora Therapeutics Reveals FDA Approval for NMRA-266 Investigational New Drug and Commences Phase 1 Human Trials
6 December 2023
NMRA-266, a molecule with selective affinity for enhancing the activity of the M4 muscarinic receptor, is being advanced by Neumora as a potential therapeutic option for the management of schizophrenia as well as various additional mental health conditions.
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SpringWorks Therapeutics announced FDA approval of OGSIVEO™ (nirogacestat) as the first treatment for adult Desmoid tumor patients
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SpringWorks Therapeutics announced FDA approval of OGSIVEO™ (nirogacestat) as the first treatment for adult Desmoid tumor patients
6 December 2023
SpringWorks Therapeutics, Inc., a biopharma company focused on severe rare diseases and cancer, has announced FDA approval for OGSIVEO™ (nirogacestat), an oral gamma secretase inhibitor, to treat progressive desmoid tumors in adults requiring systemic therapy.
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Abeona Therapeutics Reveals FDA Approval and Priority Review Provision for Pz-cel Biologics License Application (BLA)
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Abeona Therapeutics Reveals FDA Approval and Priority Review Provision for Pz-cel Biologics License Application (BLA)
1 December 2023
Abeona Therapeutics Inc. confirms FDA priority review for their therapy, pz-cel (prademagene zamikeracel), Biologics License Application.
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Cadonilimab, a PD-1/CTLA-4 bispecific antibody, met its primary endpoint by halting progression in a Phase III recurrent/metastatic cervical cancer trial
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Cadonilimab, a PD-1/CTLA-4 bispecific antibody, met its primary endpoint by halting progression in a Phase III recurrent/metastatic cervical cancer trial
1 December 2023
In the Phase III trial for the initial treatment of recurrent/metastatic cervical cancer in all types of patients, Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) has achieved the primary goal of halting disease progression.
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Gracell Biotechnologies announces FDA clearance for a Phase 1/2 trial of FasTCAR-T GC012F for treatment-resistant Systemic Lupus Erythematosus
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Gracell Biotechnologies announces FDA clearance for a Phase 1/2 trial of FasTCAR-T GC012F for treatment-resistant Systemic Lupus Erythematosus
1 December 2023
Gracell Biotechnologies reveals FDA approval for a Phase 1/2 Clinical Trial IND application concerning FasTCAR-T GC012F, aimed at treating stubborn Systemic Lupus Erythematosus.
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TC BioPharm Gets Approval from FDA to Conduct Phase 1B IND for TCB-008 in Treating Acute Myeloid Leukemia
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TC BioPharm Gets Approval from FDA to Conduct Phase 1B IND for TCB-008 in Treating Acute Myeloid Leukemia
1 December 2023
TC BioPharm PLC, a clinical-stage biotech company focused on allogeneic gamma-delta T cell cancer therapies, has announced FDA approval for its investigational new drug application to enter a Phase 1B trial for recurrent and refractory Acute Myeloid Leukemia.
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OncoNano Medicine begins Phase 1 trial of ONM-501, first patient dosed for advanced solid tumors and lymphomas
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OncoNano Medicine begins Phase 1 trial of ONM-501, first patient dosed for advanced solid tumors and lymphomas
1 December 2023
The first participant has been dosed in OncoNano Medicine's Phase 1 trial of ONM-501 for individuals with advanced solid cancers and lymphomas.
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Acadia Pharmaceuticals starts the Phase 2 study of ACP-204 in treating Alzheimer's Disease-related psychosis
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Acadia Pharmaceuticals starts the Phase 2 study of ACP-204 in treating Alzheimer's Disease-related psychosis
1 December 2023
Acadia Pharmaceuticals Inc. announces Phase 2 trial to test efficacy and safety of ACP-204 for Alzheimer's-related psychosis hallucinations and delusions.
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Genmab Reports Encouraging Regulatory Progress for Epcoritamab (EPKINLY®/TEPKINLY®) in Treating Recurring/Resistant Follicular Lymphoma
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Genmab Reports Encouraging Regulatory Progress for Epcoritamab (EPKINLY®/TEPKINLY®) in Treating Recurring/Resistant Follicular Lymphoma
1 December 2023
Genmab A/S provided updates on FDA and EMA regulatory progress concerning their bispecific T-cell engaging antibody, epcoritamab, which is administered subcutaneously and under review.
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GSK reveals positive results in phase III DREAMM-7 study comparing Blenrep for relapsed or refractory multiple myeloma
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GSK reveals positive results in phase III DREAMM-7 study comparing Blenrep for relapsed or refractory multiple myeloma
1 December 2023
GSK reports encouraging outcomes from the DREAMM-7 phase III comparative study of Blenrep for recurrent or resistant multiple myeloma.
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Formycon has declared the submission of FYB203, a biosimilar candidate for Eylea® (Aflibercept), to the EMA
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Formycon has declared the submission of FYB203, a biosimilar candidate for Eylea® (Aflibercept), to the EMA
1 December 2023
Formycon AG, in collaboration with its licensing associate Klinge Biopharma GmbH, has declared the submission of the commercial application for FYB203 to the European Medicines Agency.
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