Aquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment   Aquestive Therapeutics, a pharmaceutical company specializing in advancing medicines to improve patients' lives, has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for their product Libervant™ (diazepam) Buccal Film. The NDA is specifically for the..
Aldeyra Therapeutics has reported that its Phase III trial of Reproxalap, a drug for treating allergic conjunctivitis and dry-eye disease, has produced positive results. The liquid eye drop formulation of the small-molecule modulator of reactive aldehyde species demonstrated statistically significant reductions in eye itchiness across the 11 primary endpoint comparisons for patients treated with..
Roche and AbbVie are set to compete in the lymphoma market with their newly approved bispecific antibodies (BsAbs). Four weeks after AbbVie's Epkinly was approved, the FDA has given its approval for Roche's Genentech's BsAb, Columvi. Both drugs will be available this summer, leading to a head-to-head competition between the two companies. These therapies utilize bispecific antibody design to bin..
Amneal Pharmaceuticals has received 505(b)(2) New Drug Application (NDA) approval from the US Food and Drug Administration for PEMRYDI RTU, a ready-to-use presentation of pemetrexed for injection. The treatment is indicated in combination with pembrolizumab and platinum chemotherapy for initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK geno..
Seattle Genetics, known as Seagen, has announced positive results from its Phase II trial for early-stage classical Hodgkin lymphoma. The company reported that Adcetris, in combination with Bristol Myers Squibb’s PD-1 inhibitor and standard chemotherapy agents, led to complete remission in 93% of patients. In Part C of the three-part study, which involved 150 patients, Adcetris showed a 98% over..
Ironwood Pharmaceuticals has announced that LINZESS has been approved by the US Food and Drug Administration (FDA) as a once-daily treatment for functional constipation in pediatric patients aged six to 17 years old. Functional constipation is a chronic condition characterized by hard, infrequent bowel movements that are often difficult or painful to pass, affecting an estimated six million chil..
Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug should be administered by continuous infusion not to exceed 24..
Medical technology company Inspire Medical Systems has received approval from the US Food and Drug Administration for an expanded indication that increases the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index warning in labeling to 40 from 32. The update will provide a safe and effective treatment option for patients with moderate to se..
Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, has received FDA approval for its generic version of Dexmedetomidine Hydrochloride Injection, which is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. The drug will be available in 50mL and 100mL and will help reduce recent supply issues experience..
