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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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide 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 Introduction Hide Introduction