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In Brief: Avelumab (Bavencio) for Metastatic Merkel Cell Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Jul 17, 2017 (Issue 1525)
-human programmed death
ligand 1 (PD-L1) blocking antibody avelumab (Bavencio –
EMD Serono/Pfizer ...
The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are diagnosed each year with MCC. Most of these patients can be treated with surgical resection, but ~50% will have a recurrence and >30% will eventually have metastatic disease. Median progression-free...
Telotristat Ethyl (Xermelo) for Carcinoid Syndrome Diarrhea
The Medical Letter on Drugs and Therapeutics • Jul 17, 2017 (Issue 1525)
syndrome occurs
in about 20% of patients with neuroendocrine
tumors.1 It is characterized by diarrhea ...
The FDA has approved telotristat ethyl (Xermelo –
Lexicon), a tryptophan hydroxylase inhibitor, for
use in combination with a somatostatin analog
(SSA) for treatment of carcinoid syndrome diarrhea
inadequately controlled with SSA therapy alone.
Telotristat ethyl is the first oral drug to be approved
in the US for this indication.
Ocrelizumab (Ocrevus) for MS
The Medical Letter on Drugs and Therapeutics • Jun 19, 2017 (Issue 1523)
of symptom onset.1,2
Pronunciation Key
Ocrelizumab: oc” re liz’ ue mab Ocrevus: oak' rev us
Primary ...
The FDA has approved ocrelizumab (Ocrevus –
Genentech), a humanized anti-CD20 monoclonal
antibody, for treatment of adults with primary
progressive or relapsing multiple sclerosis (MS). It is the
first anti-CD20 monoclonal antibody to be approved for
treatment of MS and the first disease-modifying drug
to be approved in the US for primary progressive MS.
Acetylcysteine (Cetylev) for Acetaminophen Overdose
The Medical Letter on Drugs and Therapeutics • Jun 19, 2017 (Issue 1523)
healthy adults were randomized to
Table 1. Acetylcysteine Formulations for Treatment of Acetaminophen ...
The FDA has approved an effervescent tablet
formulation of acetylcysteine (Cetylev – Arbor) to
prevent or lessen hepatic injury after acetaminophen
overdose. Acetylcysteine has been available for years
in an IV solution (Acetadote, and generics) and an oral
solution for the same indication; use of the oral solution
has been limited by its unpleasant odor and taste.
Abaloparatide (Tymlos) for Postmenopausal Osteoporosis
The Medical Letter on Drugs and Therapeutics • Jun 19, 2017 (Issue 1523)
for this indication inhibit
bone resorption.1
Abaloparatide (Tymlos) for
Postmenopausal Osteoporosis
small ...
The FDA has approved abaloparatide (Tymlos –
Radius Health), a synthetic analog of human
parathyroid hormone related peptide, for treatment
of postmenopausal women with osteoporosis who
are at high risk for fracture. Abaloparatide is the
second parathyroid hormone receptor agonist to be
approved for this indication; teriparatide (Forteo –
Lilly), a recombinant parathyroid hormone analog,
was the first. They are the only drugs approved
for treatment of osteoporosis that stimulate bone
formation. Other drugs used for this indication inhibit
bone resorption.
Obalon Balloon System - Another Gastric Balloon for Weight Loss
The Medical Letter on Drugs and Therapeutics • Jun 19, 2017 (Issue 1523)
and exercise. Two
other gastric balloon devices, ReShape and Orbera,
were approved earlier.1
Pronunciation ...
The FDA has approved the Obalon Balloon System
(Obalon), a swallowable intragastric gas-filled balloon
device, to facilitate weight loss in adults with a body
mass index (BMI) of 30-40 kg/m2 who have not been
able to lose weight through diet and exercise. Two
other gastric balloon devices, ReShape and Orbera,
were approved earlier.
Riboflavin (Photrexa) and Ultraviolet Light for Progressive Keratoconus
The Medical Letter on Drugs and Therapeutics • Jun 19, 2017 (Issue 1523)
with an incidence of about
1 in 1750. It usually presents in adolescence and
progresses for one to two decades.1 ...
The FDA has approved the ophthalmic solutions
riboflavin 5'-phosphate in 20% dextran (Photrexa
Viscous – Avedro) and riboflavin 5'-phosphate alone
(Photrexa) for use with ultraviolet A (UVA) light
(KXL System) in the corneal collagen cross-linking
treatment of two corneal disorders: progressive
keratoconus and corneal ectasia following refractive
surgery. It is the first corneal collagen cross-linking
(CXL) treatment to be approved by the FDA.
Abuse-Deterrent Opioids
The Medical Letter on Drugs and Therapeutics • Jun 05, 2017 (Issue 1522)
last article on
this subject,1 several new abuse-deterrent opioid
formulations have been approved ...
Development of abuse-deterrent opioid products,
including reformulation of existing products, has
become a priority for drug manufacturers and
public health advocates. Since our last article on
this subject, several new abuse-deterrent opioid
formulations have been approved by the FDA,
including an oxycodone tablet formulation (Roxybond
– Inspirion) that is the first immediate-release opioid
product FDA-approved to include claims of abuse
deterrence in its labeling. No opioid formulation
prevents consumption of a large number of intact
dosage units, the most common method of...
Oxymetazoline Cream (Rhofade) for Rosacea
The Medical Letter on Drugs and Therapeutics • May 22, 2017 (Issue 1521)
receptor agonist oxymetazoline as a 1% cream (Rhofade
– Allergan) for topical treatment of persistent ...
The FDA has approved the selective alpha1A-adrenergic
receptor agonist oxymetazoline as a 1% cream (Rhofade
– Allergan) for topical treatment of persistent facial
erythema of rosacea in adults. Brimonidine, a selective
alpha2-adrenergic receptor agonist, was approved in
2013 as a 0.33% gel (Mirvaso) for the same indication.
Like Mirvaso, Rhofade is not indicated for treatment of
inflammatory lesions of rosacea. Oxymetazoline has
been available over the counter for many years as a
nasal decongestant spray (Afrin, and others).
Valbenazine (Ingrezza) for Tardive Dyskinesia
The Medical Letter on Drugs and Therapeutics • May 22, 2017 (Issue 1521)
in adults.1 It is the first drug to
be approved in the US for this indication; two other
VMAT2 inhibitors ...
The FDA has approved valbenazine (Ingrezza –
Neurocrine Biosciences), a vesicular monoamine
transporter 2 (VMAT2) inhibitor, for treatment of
tardive dyskinesia in adults. It is the first drug to
be approved in the US for this indication; two other
VMAT2 inhibitors, tetrabenazine (Xenazine, and
generics) and deutetrabenazine (Austedo), were
approved earlier for treatment of chorea associated
with Huntington's disease.