This was the first study to demonstrate the safety of peanut oral immunotherapy among preschool-aged children when administered as routine therapy in a hospital or clinic instead of a clinical trial setting.
TherapeuticsMD announced the launch of Bijuva (estradiol and progesterone) capsules for use in women with a uterus for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.
Viracta Therapeutics announced that the FDA has granted Orphan Drug designation to nanatinostat (VRx-3996), in combination with valganciclovir, for the treatment of post-transplant lymphoproliferative disorder.
Gelesis announced that the Food and Drug Administration (FDA) has cleared Plenity (Gelesis100) to aid in weight management for overweight and obese adults, in conjunction with diet and exercise. Available in capsule form, Plenity, a non-systemic, superabsorbent hydrogel, is intended for use in adults with a body mass index (BMI) of 25–40kg/m2 and is taken…
The approval was supported by data from a phase 2 multicenter, open-label, single-arm trial (N=87) of patients with locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 genetic alterations that had progressed following treatment with chemotherapy.
Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
The final rule states that certain active ingredients are not allowed to be used in OTC hand sanitizers, which are meant for use without water and soap.
Sanofi announced plans to expand its ‘insulins Valyou Savings Program’ that will further reduce the cost of Sanofi insulins for patients with diabetes. The Insulins Valyou Savings Program was launched a year ago to set the price for cash-paying patients at $99 for one 10mL vial or $149 for one box of pens. Now, the…
Results from the phase 3b ALPINE study, which evaluated Aristada (aripiprazole lauroxil; Alkermes) and Invega Sustenna (paliperidone palmitate; Janssen) in patients experiencing an acute exacerbation of schizophrenia, showed that both of these long-acting injectable treatments effectively controlled schizophrenia symptoms
United Therapeutics reported that following disappointing results from the BEAT study (NCT01908699), the company has decided to discontinue the development of esuberaprost for the treatment of pulmonary arterial hypertension.
