Hormone Therapy for Transgender Patients Potentially Safer Than Previously Thought
Despite extended exposure to high doses of estrogen therapy, levels of prolactin did not rise in transgender patients.
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FDA Accepts NDA for Mayne Pharma's SUBA-Itraconazole Capsule for Fungal Infections
The unique formulation of SUBA-Itraconazole capsules, which has improved bioavailability and significantly reduced variability, represents a substantial innovation.
FDA Advisory Committee Supports TPOXX Treatment for Smallpox
If approved, TPOXX would be the first available therapy for smallpox.
Scynexis's SCY-078 Receives FDA QIDP, Fast Track Designation for Vulvovaginal Candidiasis
The enrollment for the phase 2b DOVE study in VC is completed and the top-line data is expected by July 2018.
FDA Approves Medtronic's Deep Brain Stimulation Therapy for Refractory Epilepsy
The 7-year data showed the median seizure frequency reduction of 75% in those with drug-resistant epilepsy with partial-onset seizures receiving DBS therapy.
FDA Green Lights Medtronic's Infuse Bone Graft in New Spine Surgery Indications
Two additional implants are added to the current spine labeling.
Actelion Submits sNDA of Macitentan for Treatment of CTEPH
The filing is supported by data from MERIT-1 which showed great improvements in pulmonary vascular resistance and 6-minute walk distance versus ongoing background therapy.
Ibalizumab Made Commercially Available for HIV Patients With Limited Treatment Options
This is the first drug in a new class of antiretroviral medications that does not require daily dosing and can greatly provide benefit to patients who have run out of HIV treatment options.
Netarsudil Ophthalmic Solution (Rhopressa) Launches in United States
The solution to lower elevated intraocular pressure is approved 2 months ahead of the scheduled PDFUA date.
FDA Grants Orphan-Drug Designation for ELX-02 in Treatment of Cystinosis
The investigational drug programs represent a high unmet medical need as there are currently no approved therapeutics targeting the impairment caused by the mutations.
FDA Links Lamotrigine to Serious Immune System Reaction
The agency warns that the seizure and bipolar disorder medication can cause hemophagocytic lymphohistiocytosis, a rare but very serious immune system reaction.
FDA Green Lights ThinPrep Integrated Imager for Pap Testing in More Labs
Use of the device is appropriate for small- and mid-sized laboratories.
FDA Accepts Supplemental Biologics License Application for .5 mL Influenza Vaccine in Children 6-35 Months
If approved, the same 0.5 mL dose vaccination can be used with all patients ages 6 months and older for whom flu vaccination is recommended.
FDA OKs Tolvaptan, First Treatment to Slow Kidney Function Decline
Data from the 2 clinical trials showed that JYNARQUE slowed kidney function decline in adults at risk of rapidly progressing ADPKD.
FDA Advisory Committee Recommends Lower Dose of Baricitinib for Rheumatoid Arthritis
The committee recommends the approval of baricitinib 2-mg, but not 4-mg; this comes a year after baricitinib was rejected by the FDA.
Sage Therapeutics Files NDA for Brexanolone in Postpartum Depression Treatment
Brexanolone received breakthrough therapy designation in September 2016, underscoring the significant unmet need in women suffering from postpartum depression.
FDA Greenlights PartoSure to Assess Spontaneous Preterm Birth Risk
A positive PartoSure test was more than 4 times as reliable as a positive fetal fibronectin test, the only other FDA-approved test for assessing the risk of preterm delivery.
Marijuana-Derived Cannabidiol for Seizures Receives Unanimous FDA Committee Backing
Monthly seizures were reduced by about 40% in those taking Epidiolex.
Text Messaging Tool Aids in Curbing Opioid Abuse
After 3 months, half of the patients reported no substance abuse, while the number of patients using drop to 2 (10%).
Research Refutes CD32 as HIV Latent Reservoir Marker
Findings indicate that the CD32 molecule is not preferential biomarker to identify HIV silent reservoirs, but instead identifies cells that are actively infected in spite of ART.
FDA Approves Recombinant Therapy for Patients with von Willebrand Disease
Treatment now offers an individualized approach to control bleeding in appropriate patients undergoing surgery.
Transgender, Gender-Nonconforming Youth Suffer More Mental Health Conditions Than Cisgender Counterparts
Transgender/gender-nonconforming youth may present with mental health conditions that require immediate evaluation and implementation gender identity support measures.
FDA Announces New Approval of Daptomycin For Injection in Adult Patients
Daptomycin for injection is an affordable generic antibiotic alternative to Cubicin.
TransMedics' OCS Lung System Receives FDA Pre-Market Approval
The device reduces ischemic time in lung transplantation while enabling longer, safe out-of-body time of the allograft.
FDA Grants Reviva Pharmaceuticals' RP5063 Orphan Designation for IPF
The findings indicate the potential for a clinically meaningful improvement and stabilization of lung function.
FDA Restricts Sale and Distribution of Bayer's Essure Device
Patients must also receive a brochure and sign risk acknowledgment.
Upadacitinib Demonstrates Positive Rheumatoid Arthritis Results in SELECT-COMPARE Trial
Upadacitinib (15 mg, once-daily) met both primary endpoints, with 71% of patients achieving ACR20 and 29% achieving clinical remission at week 12.
Amir Kashani, MD, PhD: Stem-Cell Based Therapy for Dry Age-Related Macular Degeneration
A novel subretinal implantation of a stem cell-based bioengineered patch may restore vision or prevent further vision loss.
PARADIGM-HF Post-Hoc Analysis Shows Sacubitril/Valsartan Significantly Improves Physical, Social Activity
Physical and social improvements were observed in the 8-month visit, but importantly, were sustained in the 3-year follow-up period.
FDA Approves Exenatide Expanded Indication for Type 2 Diabetes
Study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy versus insulin glargine alone.