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Berdazimer Gel (Zelsuvmi) for Molluscum Contagiosum

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available ...
Berdazimer 10.3% gel (Zelsuvmi – Ligand), a first-in-class nitric oxide-releasing agent, has been approved by the FDA for topical treatment of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available in the US for treatment of molluscum contagiosum and the first that can be applied by the patient or caregiver at home; cantharidin 0.7% solution (Ycanth), which is applied by a healthcare professional, was approved earlier for use in patients ≥2 years old.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):113-4   doi:10.58347/tml.2025.1733a |  Show IntroductionHide Introduction

COVID-19 Update: Full Approval for Novavax COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based ...
Nuvaxovid, the adjuvanted protein subunit COVID-19 vaccine marketed by Novavax, has received full approval from the FDA to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in all adults ≥65 years old and in adults 12-64 years old who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. The vaccine was previously available under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old.1 Nuvaxovid is the first protein-based COVID-19 vaccine to receive full approval from the...
Med Lett Drugs Ther. 2025 Jul 21;67(1733):118-9   doi:10.58347/tml.2025.1733f |  Show IntroductionHide Introduction

Penpulimab (Anniko) for Nasopharyngeal Carcinoma (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination ...
Penpulimab-kcqx (Anniko – Akeso Biopharma), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma and for use as monotherapy for metastatic disease in adults with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Penpulimab is the second immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma;...
Med Lett Drugs Ther. 2025 Jul 21;67(1733):e122-3   doi:10.58347/tml.2025.1733k |  Show IntroductionHide Introduction

COVID-19 Update: mRNA COVID-19 Vaccines and Myocarditis

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
typically in the first week following vaccination, are highest in males 12-24 years old.1 The FDA ...
The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):119   doi:10.58347/tml.2025.1733g |  Show IntroductionHide Introduction

COVID-19 Update: mNEXSPIKE — A New Moderna mRNA Vaccine for COVID-19

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19.1 ...
The FDA has licensed mNEXSPIKE (Moderna), an mRNA vaccine, for prevention of COVID-19 in adults ≥65 years old and in persons 12-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19. Spikevax, the original Moderna mRNA COVID-19 vaccine, remains in production2; it is licensed for use in persons ≥12 years old and is available under an Emergency Use Authorization (EUA) for children 6 months to 11 years old.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):119-20   doi:10.58347/tml.2025.1733h |  Show IntroductionHide Introduction

Onapgo — An Apomorphine Subcutaneous Infusion for Parkinson's Disease

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
). Subcutaneously injected apomorphine (Apokyn, and generics) has been available for intermittent use for years.1 ...
Onapgo (Supernus), a solution for continuous subcutaneous infusion containing the dopamine agonist apomorphine, has been approved by the FDA for treatment of motor fluctuations in adults with advanced Parkinson's disease (PD). Subcutaneously injected apomorphine (Apokyn, and generics) has been available for intermittent use for years. Vyalev, a foscarbidopa/foslevodopa solution for subcutaneous infusion, was approved in 2024 for the same indication.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):116-8   doi:10.58347/tml.2025.1733d |  Show IntroductionHide Introduction

Avmapki Fakzynja Co-Pack for Ovarian Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
. ▶ Dosage: Avutometinib: 3.2 mg taken twice weekly on days 1 and 4. Defactiib: 200 mg twice daily. Both ...
Avmapki Fakzynja Co-Pack (Verastem), a combination of the kinase inhibitors avutometinib and defactinib, has received accelerated approval from the FDA for treatment of KRAS-mutated recurrent low-grade serous ovarian cancer in women who had previously received systemic therapy. Neither drug is approved for use as monotherapy for any indication. Avmapki Fakzynja is the first treatment to be approved in the US for this indication.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):e120-1   doi:10.58347/tml.2025.1733j |  Show IntroductionHide Introduction

Prademagene Zamikeracel (Zevaskyn) for Recessive Dystrophic Epidermolysis Bullosa (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
1 vector-based gene therapy, is approved for once-weekly use in patients ≥6 months old ...
Prademagene zamikeracel (Zevaskyn – Abeona Therapeutics), an autologous cell sheet-based gene therapy, has been approved by the FDA for treatment of wounds in patients with recessive dystrophic epidermolysis bullosa. It is the first autologous cell sheet-based gene therapy to be approved in the US for this indication. Beremagene geperpavek gel (Vyjuvek), a herpes simplex virus type 1 vector-based gene therapy, is approved for once-weekly use in patients ≥6 months old with recessive dystrophic epidermolysis bullosa.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):e124-5   doi:10.58347/tml.2025.1733l |  Show IntroductionHide Introduction

Retifanlimab (Zynyz) for Anal Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
(Zynyz – Incyte), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA ...
Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as monotherapy in patients who had disease progression or intolerance to platinum-based chemotherapy. The drug received accelerated approval for treatment of recurrent locally advanced or metastatic Merkel cell carcinoma in 2023.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):e126-7   doi:10.58347/tml.2025.1733m |  Show IntroductionHide Introduction

Upadacitinib (Rinvoq) for Giant Cell Arteritis

   
The Medical Letter on Drugs and Therapeutics • Jul 21, 2025  (Issue 1733)
, ulcerative colitis, and Crohn’s disease.1-4 THE DISORDER — Giant cell arteritis is a systemic large-vessel ...
The oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) has been approved by the FDA for treatment of giant cell arteritis. Upadacitinib was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.
Med Lett Drugs Ther. 2025 Jul 21;67(1733):114-5   doi:10.58347/tml.2025.1733b |  Show IntroductionHide Introduction