The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

Shots: The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs) Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength Forzinity is a mitochondrial cardiolipin binder. It…

ByDipanshu DixitSeptember 19, 2025

NEWS

Eli Lilly to Acquire Verve Therapeutics for ~$1.3B

Shots:Eli Lilly has entered into a definitive agreement to acquire Verve Therapeutics to advance cardiovascular therapiesAs per the deal, Lilly will acquire Verve for $10.50/share in an all-cash transaction totaling ~$1B, along with one non-tradeable CVR of $3/share tied to first pts dosing with VERVE-102 for ASCVD in P-III trial by year 10 post-closing;…

ByRidhi RastogiJune 17, 2025

NEWS

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

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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

The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

Eli Lilly to Acquire Verve Therapeutics for ~$1.3B

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

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