New Drug Approval 127

New Drug Approval

Active Ingredient Approval Date FDA-approved use on approval date
Concizumab-mtci 12/20/2024 For routine prophylaxis to prevent bleeding episodes in
hemophilia A and B
Vanzacaftor, tezacaftor, 12/20/2024 To treat cystic fibrosis
and deutivacaftor
Olezarsen 12/19/2024 To treat familial chylomicronemia syndromeDrug Trials
Snapshot
Ensartinib 12/18/2024 To treat non-small cell lung cancer
Cosibelimab-ipdl 12/13/2024 To treat cutaneous squamous cell carcinoma
Crinecerfont 12/13/2024 To treat classic congenital adrenal hyperplasia Press Release
Zenocutuzumab-zbco 12/4/2024 To treat non-small cell lung cancer and pancreatic
adenocarcinoma
Iomeprol 11/27/2024 For use as a radiographic contrast agent
Acoramidis 11/22/2024 To treat cardiomyopathy of wild-type or variant transthyretin-
mediated amyloidosis Drug Trials Snapshot
Landiolol 11/22/2024 To treat supraventricular tachycardia
Zanidatamab-hrii 11/20/2024 To treat unresectable or metastatic HER2-positive (IHC 3+)
biliary tract cancer Drug Trials Snapshot
Revumenib 11/15/2024 To treat relapsed or refractory acute leukemia
Sulopenem etzadroxil, 10/25/2024 To treat uncomplicated urinary tract infections (uUTI) Drug
probenecid Trial Snapshot
Zolbetuximab-clzb 10/18/2024 To treat gastric or gastroesophageal junction adenocarcinoma
Drug Trials Snapshots: VYLOY
Marstacimab-hncq 10/11/2024 To prevent or reduce bleeding episodes related to hemophilia A
or BPress ReleaseDrug Trials Snapshot
Inavolisib 10/10/2024 To treat locally advanced or metastatic breast cancer Drug
Trials Snapshot
Flurpiridaz F 18 9/27/2024 A radioactive diagnostic drug to evaluate for myocardial
ischemia and infarction
Xanomeline and 9/26/2024 To treat schizophrenia Press Release Drug Trials Snapshot
trospium chloride
Levacetylleucine 9/24/2024 To treat Niemann-Pick disease type CPress Release Drug
Trials Snapshot
Arimoclomol 9/20/2024 To treat Niemann-Pick disease type CPress Release Drug
Trials Snapshot
128 New Drug Approval

Lebrikizumab-lbkz 9/13/2024 To treat moderate-to-severe atopic dermatitis Drug Trials

Snapshot
Lazertinib 8/19/2024 To treat non-small cell lung cancer Drug Trials Snapshot
Axatilimab-csfr 8/14/2024 To treat chronic graft-versus-host disease (cGVHD) Drug
Trials Snapshot
Seladelpar 8/14/2024 To treat primary biliary cholangitis (PBC)Drug Trials Snapshot
Nemolizumab-ilto 8/12/2024 To treat prurigo nodularis Drug Trials Snapshot
Palopegteriparatide 8/9/2024 To treat hypoparathyroidism Drug Trials Snapshot
Vorasidenib 8/6/2024 To treat Grade 2 astrocytoma or oligodendroglioma Drug
Trials Snapshot
Deuruxolitinib 7/25/2024 To treat severe alopecia areata Drug Trials Snapshot
Donanemab-azbt 7/2/2024 To treat Alzheimer’s disease Drug Trials Snapshot
Ensifentrine 6/26/2024 To treat chronic obstructive pulmonary disease Drug Trials
Snapshot
Crovalimab-akkz 6/20/2024 To treat paroxysmal nocturnal hemoglobinuria Drug Trials
Snapshot
Sofpironium 6/18/2024 To treat primary axillary hyperhidrosis Drug Trials Snapshot
Elafibranor 6/10/2024 To treat primary biliary cholangitis in combination with
ursodeoxycholic acid Drug Trials Snapshot
Imetelstat 6/6/2024 To treat low- to intermediate-1 risk myelodysplastic syndromes
Drug Trials Snapshot
References: Drugs.com
New Drug Molecules and Gene Therapies Approval
Indication Approval 129

New Drug Indication Approval

Over the past six months (July 2024 to January Indication: Adjunct to diet to reduce triglycerides in
2025), the U.S. Food and Drug Administration adults with familial chylomicronemia syndrome.
(FDA) has approved several novel drug therapies. Approval Date: December 19, 2024
Here is a list of these newly approved drugs, along Ryoncil (remestemcel-L-rknd)
with their indications and approval dates:
Indication: Treatment of steroid-refractory acute
Datroway (datopotamab deruxtecan-dlnk) graft versus host disease in pediatric patients 2
Indication: Treatment of advanced breast cancer in months of age and older.
patients who have previously undergone Approval Date: December 18, 2024
treatment.
Ensacove (ensartinib)
Approval Date: January 17, 2025
Indication: Treatment of ALK-positive non-small
Lumakras (sotorasib) in combination with cell lung cancer.
Vectibix (panitumumab)
Approval Date: December 18, 2024
Indication: Treatment of metastatic colorectal cancer
Steqeyma (ustekinumab-stba)
in patients with a specific KRAS gene mutation,
Indication: Treatment of plaque psoriasis, psoriatic
whose cancer has progressed despite
arthritis, Crohn's disease, and ulcerative colitis.
chemotherapy.
Approval Date: December 17, 2024
Approval Date: January 16, 2025
Crenessity (crinecerfont)
Omvoh
Indication: Treatment of adults with moderate-to- Indication: Adjunctive treatment to glucocorticoid
severe Crohn's disease. replacement to control androgens in adults and
pediatric patients 4 years of age and older with
Approval Date: January 15, 2025
classic congenital adrenal hyperplasia.
Alhemo
Approval Date: December 13, 2024
Indication: Prevention or reduction of bleeding
Unloxcyt (cosibelimab-ipdl)
episodes in patients aged 12 and above with
hemophilia and antibodies against clotting factor Indication: Treatment of cutaneous squamous cell
replacement treatments. carcinoma.

Approval Date: December 20, 2024 Approval Date: December 13, 2024

Zepbound (tirzepatide) Bizengri (zenocutuzumab-zbco)

Indication: Treatment of obstructive sleep apnea in Indication: Treatment of neuregulin 1 fusion

positive (NRG1+) non-small cell lung cancer and
adults with obesity, to be used alongside a
reduced-calorie diet and increased physical NRG1+ pancreatic adenocarcinoma.
activity. Approval Date: December 4, 2024
Approval Date: December 20, 2024 Yesintek (ustekinumab-kfce)
Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) Indication: Treatment of plaque psoriasis, psoriatic
Indication: Treatment of cystic fibrosis. arthritis, Crohn's disease, and ulcerative colitis.

Approval Date: December 20, 2024 Approval Date: November 29, 2024

Tryngolza (olezarsen) Attruby (acoramidis)

130 New Indication Approval
Newfor Drug
Existing Drugs
Approval

Indication: Treatment of the cardiomyopathy of

wild-type or variant transthyretin-mediated References: Drugs.com
amyloidosis in adults to reduce cardiovascular
death and cardiovascular-related hospitalization.
Approval Date: November 22, 2024

Information collected and compiled by

Md. Akbar Hossain
Dhaka International University, Satarkul, Badda, Dhaka-1212, Bangladesh

New Indication Approval for Existing Drugs

Here is a list of some recent drug approvals with new New Indication: Approved as a combination therapy
indications for existing drugs, highlighting their new for colorectal cancer with a specific KRAS gene
indications, approval dates, and old indications: mutation.
Omvoh (etrasimod) Approval Date: January 17, 2025.
New Indication: Approved for moderate-to-severe Old Indications: Lumakras was initially approved
Crohn's disease. for non-small cell lung cancer (NSCLC), while
Approval Date: January 15, 2025. Vectibix is used for colorectal cancer without a
KRAS mutation.
Old Indication: Previously approved for moderate-
to-severe active ulcerative colitis. Datroway (datopotamab deruxtecan)

Zunveyl (benzgalantamine) New Indication: Approved for advanced breast

cancer in patients who have already undergone
New Indication: Approved for mild to moderate
treatment.
Alzheimer's disease.
Approval Date: January 17, 2025.
Approval Date: Expected by March 2025.
Old Indication: Initially approved for use in treating
Old Indication: A reformulation of Razadyne, an
certain types of solid tumors.
Alzheimer's drug.
Lumakras (sotorasib) and Vectibix
(panitumumab) References: Drugs.com

Information collected and compiled by

Md. Akbar Hossain
Dhaka International University, Satarkul, Badda
Dhaka-1212, Bangladesh
New Drug
Herbal drugMolecules
Approvaland Gene Therapies Approval 131

Herbal Drug Approval

Over the past six months, several significant 3. Lianhua Qingwen's Use in COVID-19
developments have emerged in the field of herbal Treatment
medicine. Here are some notable updates: As of December 2024, Lianhua Qingwen, a
1. FDA Advises Against Using Herbal Doctor traditional Chinese herbal medicine, has been
Remedies' Products promoted for the treatment of COVID-19 in various
In July 2024, the U.S. Food and Drug Administration countries. However, its efficacy remains
(FDA) issued a warning against the use of products controversial, and health authorities in several
manufactured by Herbal Doctor Remedies. The regions have issued advisories regarding its use.
company was found to produce unapproved new References: Medical News Today
drugs, including Brain Forte, New Life, Lump 4. Introduction of Sleepinox Herbal Supplement
Shrinker, Asma-F, Herpes-P, and Anemia, which In December 2024, Dr. David Mahjoubi, a board-
have not been evaluated for safety and efficacy. certified anesthesiologist, introduced Sleepinox, a
References: U.S. Food and Drug Administration natural sleep supplement formulated with magnesium
2. Kratom Linked to Health Risks glycinate, valerian root, ashwagandha, borage oil,
In August 2024, a study highlighted the potential and L-theanine. The supplement aims to aid sleep,
liver risks associated with six popular herbal enhance cognitive function, and boost the immune
supplements, including green tea extract and system without the use of melatonin.
curcumin. The research indicated that millions in the Reference: New York Post
U.S. might be at risk of liver damage from these
herbal remedies.
References: Medical News Today

References: Drugs.com

Information collected and compiled by

Md. Akbar Hossain
Dhaka International University, Satarkul, Badda
Dhaka-1212, Bangladesh