Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

Shots:The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…

ByRidhi RastogiFebruary 6, 2025

News

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

Shots:FDA has granted FTD to Cu-64 SAR-bisPSMA for PET scans of PSMA+ lesions in pts with BCR post-receiving SoC, based on a P-I/II (COBRA) trial assessing it (same & next day) in patients who had an SoC scan at study entry Study showed that it localized disease in ~80% patients & detected double the…

ByRidhi RastogiJanuary 27, 2025

News

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Shots:The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib. In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted…

ByDipanshu DixitJanuary 14, 2025

INSIGHTS+

New Drug Designations – August 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices In August 2024, Invenra’s INV724 received the…

BySenior EditorSeptember 25, 2024

INSIGHTS+

New Drug Designations – May 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices This…

BySenior EditorJune 25, 2024

INSIGHTS+

New Drug Designations – April 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…

BySenior EditorMay 30, 2024

INSIGHTS+

New Drug Designations – March 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices Trellis Bioscience's…

BySenior EditorApril 30, 2024

INSIGHTS+

New Drug Designations – February 2024

Shots:PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…

BySenior EditorMarch 28, 2024

VIEWPOINTS

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

Shots: In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma With a fast-track designation and breakthrough therapy…

BySaurabh ChaubeyMarch 7, 2024

INSIGHTS+

New Drug Designations – January 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine NRx Pharmaceuticals’ NRX-101 small molecule, focused…

BySenior EditorFebruary 20, 2024

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement

The US FDA Grants Fast Track Designation to Clarity’s Cu-64 SAR-BisPSMA in Biochemical Recurrence of Prostate Cancer

The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

New Drug Designations – August 2024

New Drug Designations – May 2024

New Drug Designations – April 2024

New Drug Designations – March 2024

New Drug Designations – February 2024

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

New Drug Designations – January 2024

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