CLINICAL ROLE -
Stakeholders Urge FDA to Protect Access to Compounded Hormone Therapies
Prescribers signed a letter expressing concerns about recommendations for restrictions on compounded hormones, which millions of women and other patient populations rely on.
Herpes Zoster-Associated Urinary Retention Can Cause Serious Complications
Case report describes severe complications from spontaneous bladder rupture caused by herpes zoster-associated urinary retention.
FDA Approves Deucravacitinib for Adults With Moderate-to-Severe Plaque Psoriasis
Deucravacitinib (Sotyktu) may become the new standard of care oral therapy for moderate-to-severe plaque psoriasis, according to investigators.
FDA Approves Pemigatinib for Relapsed or Refractory Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement
Pemigatinib is the first targeted therapy to gain FDA approval for the treatment of adult patients with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease
Ibrutinib (Imbruvica) is the first therapy to gain FDA approval for younger patients who had no prior treatment options for chronic graft-versus-host disease.
Moderna Applies for EUA for Omicron-Targeting Bivalent COVID-19 Booster Candidate
The mRNA-1273.222 vaccine candidate targets both the original SARS-CoV-2 strain in addition to the BA.4/BA.5 subvariants of the Omicron strain.
FDA Clears Omnipod 5 Automated Insulin Delivery System for Type 1 Diabetes Patients 2 Years of Age and Older
Omnipod 5 is an automated, tubeless insulin dispensing system that allows for continuous infusion and bolus dosing as needed.
FDA Approves Companion Diagnostic for Trastuzumab Deruxtecan in HER2-Mutated Non-Small Cell Lung Cancer
The Oncomine Dx Target Test is a next-generation sequencing–based companion diagnostic developed to analyze 23 genes associated with non–small cell lung cancer in patients who harbor an activating HER2 mutation.
Study to Evaluate Efficacy of Telehealth Cognitive Behavioral Therapy for Migraine
Study will analyze whether cognitive behavioral therapy telehealth can lower headache days and disability as effectively as cognitive behavioral therapy plus a preventive medication for migraine.
Survey Finds Strong Link Between Migraine Symptoms and Mental Health
Survey finds that 91% of health care providers and 67% of people with migraines feel that individuals who are able to successfully manage stress and mental health conditions can also better manage the symptoms of migraine.
FDA Approves Belimumab for Children with Active Lupus Nephritis
Belimumab (Benlysta) the first FDA-approved therapy for pediatric lupus nephritis.
FDA Approves Ruxolitinib for Nonsegmental Vitiligo
Ruxolitinib (Opzelura; Incyte) cream 1.5% is the first and only treatment approved by the FDA for repigmentation in patients with vitiligo.
FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors
Crizotinib has also been approved to treat non-small cell lung cancer that has spread to other parts of the body and is caused by a defect in either the ALK or ROS1 gene.
Triptan Use Not Found to Increase Vascular Comorbidity Among Older Migraine Patients
Triptans are contraindicated in patients with ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral artery disease.
FDA Grants EUA to Novavax COVID-19 Vaccine for Individuals 18 Years of Age and Older.
NVX-CoV2373, a protein-based COVID-19 vaccine, may increase the country's vaccination rate for those hesitant to receive other vaccines.
Pediatric Hepatitis Levels Remain Consistent With Pre-Pandemic Levels
Hepatitis-associated emergency department visits and hospitalizations, liver transplantations, and adenovirus stool testing results in pediatric patients were not found to increase during the COVID-19 pandemic.
ProAir Digihaler Shows Promise Treating Poorly Controlled Asthma
ProAir Digihaler Inhalation Powder is indicated for the treatment or prevention of bronchospasm in those with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
FDA Revises Paxlovid EUA to Allow State-Licensed Pharmacists to Prescribe Drug Under Certain Conditions
Paxlovid treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
FDA Grants Priority Review to Mosunetuzumab for Relapsed or Refractory Follicular Lymphoma
Clinical trial results show durable responses with mosunetuzumab in advanced follicular lymphoma.
FDA Approves Lisocabtagene Maraleucel for Second-Line Large B-cell Lymphoma
Lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) approved for the second-line treatment of patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.
FDA Approves Dabrafenib Plus Trametinib for Unresectable, Metastatic Solid Tumors With BRAF V600E Mutation
In clinical trials, dabrafenib and trametinib showed meaningful efficacy in multiple BRAF-positive tumor types, including in patients with rare cancers who have no other treatment options available.
FDA Approves Expanded Indication for Vaxneuvance Pneumococcal Vaccine
Vaxneuvance is now indicated for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.
Coexisting Hepatitis B Surface Antigens, Antibodies Lead to More Severe Liver Disease
The coexistence of hepatitis B virus (HBV) surface antigens and antibodies against are an atypical serological profile for patients with chronic HBV infections.
FDA Approves Risankizumab-rzaa for Moderately to Severely Active Crohn Disease
Risankizumab-rzaa (Skyrizi) is the first and only specific interleukin-23 inhibitor approved for the treatment of adults with moderately to severely active Crohn disease.
FDA Grants EUAs to Moderna, Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
Since the COVID-19 pandemic began, more than 10.6 million children have tested positive for the virus in the United States.
Use of Intravenous Immunoglobulin Projected to Continue Growing Over Next Decade
Current development efforts in IVIG are focused on new routes of administration for immunoglobulin that can overcome the limitations of intramuscular administration.
FDA Panel Votes Unanimously to Recommend Moderna COVID-19 Vaccine in Ages 6 Through 17 Years
Data from the phase 2/3 TeenCOVE trial in adolescents met the primary immunogenicity endpoint.
FDA Approves Baricitinib for Adults With Severe Alopecia Areata
Baricitinib (Olumiant; Eli Lilly and Company) is the first systemic treatment to be approved by the FDA for severe alopecia areata, which affects an estimated 300,000 patients in the United States.
Fremanezumab Combo Effective in Reducing Monthly Migraine Days
Real-world data show fremanezumab-vfrm (Ajovy) injection plus gepants combination effective in patients with difficult-to-treat migraine.
FDA Advisory Committee Recommends EUA for Novavax COVID-19 Vaccine
The FDA Vaccines and Related Biological Products Advisory Committee voted nearly unanimously for an emergency use authorization for the Novavax COVID-19 vaccine, NVX-CoV2373, for use in individuals 18 years of age and older.
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