Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| AIM ImmunoTech | Ampligen | Locally advanced pancreatic cancer | Approval for a phase 2 trial granted by the FDA |
| NeuroSense Therapeutics | PrimeC (ciprofloxacin and celecoxib) | Amyotrophic lateral sclerosis | IND approved by the FDA |
| Oryzon Genomics | Iadademstat | Relapsed/refractory acute myeloid leukemia with FLT3 mutation | IND approved by the FDA |
| Phanes Therapeutics | PT199 | Advanced solid tumors | IND approved by the FDA |
| Palisade Bio | LB1148 | Return of bowel function in patients undergoing abdominal surgery | Study-may-proceed letter issued by the FDA |
| TC BioPharm | OmnImmune | Acute myeloid leukemia | Approval for a phase 2/3 study granted by the UK’s regulatory authority |
| Trials Initiated | |||
| Evommune | EVO101 | Inflammatory skin diseases | Initiation of phase 1 trial |
| Rani Therapeutics | RT-102 | Osteoporosis | Initiation of phase 1 trial |
| Ribon Therapeutics | RBN-3143 | Atopic dermatitis | Initiation of phase 1 trial |
| South Rampart Pharma | SRP-3D (DA) | Acute and chronic pain | Initiation of phase 1 trial |
| Plus Therapeutics | Rhenium-186 NanoLiposome | Leptomeningeal metastases | Initiation of phase 1/2 trial |
| Zentalis Pharmaceuticals | ZN-d5 | Relapsed or refractory light chain amyloidosis | Initiation of phase 1/2 trial |
| Bayer | BAY 2395840 | Diabetic neuropathic pain | Initiation of phase 2 trial |
| Jazz Pharmaceuticals | Zepzelca (lurbinectedin) | Select advanced or metastatic solid tumors | Initiation of phase 2 trial |
| Recursion | REC-994 | Cerebral cavernous malformation | Initiation of phase 2 trial |
| CARsgen Therapeutics | CT041 | CLDN18.2-positive advanced gastric/gastroesophageal junction cancer | Initiation of phase 2 trial in China |
| XNK Therapeutics | Autologous natural killer cell-based therapy plus isatuximab | Newly diagnosed multiple myeloma | Initiation of phase 2 trial in Sweden |
| AlloVir | Posoleucel | Prevention of infections from six common viruses in high-risk, allogeneic hematopoietic-cell transplant patients | Initiation of phase 3 trial |
| Visus Therapeutics | Brimochol PF | Presbyopia | Initiation of two phase 3 trials |
| Approvals | |||
| Bristol Myers Squibb | Opdualag (nivolumab and relatlimab-rmbw) | Metastatic melanoma patients age 12 years and older | Approved by the FDA |
| Marinus Pharmaceuticals | Ztalmy (ganaxolone) | Seizures associated with CDKL5-deficiency disorder | Approved by the FDA |
| Merck | Keytruda (pembrolizumab) | MSI H/dMMR advanced endometrial carcinoma | Approved by the FDA |
| Novartis | Pluvicto (lutetium Lu 177 vipivotide tetraxetan) | Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer | Approved by the FDA |
| Advanced Oxygen Therapy | Topical wound oxygen (TWO2) therapy | Diabetic foot ulcer | Approved in China |
| Moderna Therapeutics | Spikevax | COVID-19 | Approved in Canada for expanded age indication |
| CanSino Biologics | Convidecia | COVID-19 booster | Approved in Malaysia and Indonesia |
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