BioCardia: CardiAMP System to Treat Heart Failure
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the...
Moderna’s COVID-19 Vaccine SPIKEVAX Snatches FDA Approval
The US Food and Drug Administration (FDA) has recently approved Moderna’s mRNA COVID-19 vaccine, SPIKEVAX, becoming the second COVID-19 vaccine to be fully approved in the US. Now marketed under the name SPIKEVAX, the vaccine’s name references the spike-like...
FDA Designation: THE-630 to Treat Gastrointestinal Tumors
Theseus Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for THE-630 to treat patients with advanced gastrointestinal stromal tumors (GIST). GIST is the most common sarcoma of the gastrointestinal tract, and...
Azafaros: ODD for AZ-3102 to Treat GM2 Gangliosidosis
Azafaros has announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for AZ-3102 to treat GM2 gangliosidosis, including Tay-Sachs disease and Sandhoff disease. GM2 gangliosidosis, a group of rare genetic disorders that...
FDA Approval: Prophylactic Treatment for Type 3 VWD
The U.S. Food and Drug Administration (FDA) has approved Takeda Pharmaceutical’s VONVENDI to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD). VWD is the most common inherited bleeding disorder that is caused by a...
ALX Oncology: Evorpacept Receives ODD to Treat GC
The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...
Immunocore: FDA Clearance of Uveal Melanoma Drug KIMMTRAK
The U.S. Food and Drug Administration (FDA) has granted approval of Immunocore’s KIMMTRAK (tebentafusp-tebn) to treat adults who are HLA-A*02:01-positive for unresectable or metastatic uveal melanoma (mUM). Uveal melanoma is a rare and aggressive cancer of the eye, in...
Imara IND Clearance: Tovinontrine (IMR-687) to Treat HFpEF
The U.S. Food and Drug Administration (FDA) has cleared Imara’s Investigational New Drug (IND) application for tovinontrine (IMR-687) to treat heart failure with preserved ejection faction (HFpEF). HFpEF (diastolic heart failure) is a form of heart failure that occurs...
Pidnarulex: FDA Fast Track to Treat Solid Tumors
Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast...
FDA Approval: IND for APS03118 to Treat Multiple Cancers
In regulatory news today, the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application from Applied Pharmaceutical Science for its breakthrough drug, APS03118, to target multiple advanced cancer types. APS03118 has...
Drug Designation for AO-176: Treatment for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Arch Oncology’s next-generation anti-CD47 IgG2 antibody, AO-176, for the treatment of relapsed/refractory multiple myeloma (r/r MM). Multiple myeloma is a cancer of mature plasma...
VYVGART: Approval for Treatment of Myasthenia Gravis
Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved agrenx SE’s VYVGART (efgartigimod alfa) intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult patients who did not see improvements from pervious treatment with...
Investigational New Drug: CX-904 To Treat Solid Tumors
The U.S. Food and Drug Administration (FDA) has granted clearance of CytomX and Amgen’s Investigational New Drug Application (IND) for CX-904, a T-cell-engaging bispecific antibody, to treat advanced solid tumors. Solid tumors can be malignant or benign, typically...
Diadem’s AlzoSure Predict: Breakthrough Device Designation
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Diadem’s AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify early signs of Alzheimer’s disease and determine the potential rate of progression in...
FDA Approval: AbbVie’s RINVOQ to Treat Atopic Dermatitis
AbbVie has announced the U.S. Food and Drug Administration (FDA) approval for RINVOQ (upadacitinib) to treat refractory, moderate to severe atopic dermatitis in children 12 years and older and adults. Atopic dermatitis, more commonly known as eczema, is a chronic skin...
FDA IND Clearance: Topical Agent to Treat Dry Eye Disease
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease. Dry eye disease is a common, chronic, immune-mediated disease that is...
CBMG: FDA Designations for Cell Therapy to Treat DLBCL
The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...
FDA IND Approval: SNIPR001 to Target E. coli Infections
SNIPR BIOME has announced the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for SNIPR001 to target E. coli infections in cancer patients. E. coli bacteria live in the intestines of healthy people and while most...
Advanced NSCLC: EC Approval of Lumykras Treatment
The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes...
FDA sNDA: REXULTI to Treat Pediatric Schizophrenia
The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that is...