Oyster Point’s New Drug Application (NDA) for the dry eye disease therapy OC-01 was accepted for FDA regulatory review on the back of positive Phase III data.
The U.S. Food and Drug Administration approved Kala Pharmaceuticals’ Eysuvis for the short-term treatment of dry eye disease.
Takeda Pharmaceutical Co. trimmed the company’s full-year fiscal 2019 loss forecast on strong sales of core drugs and progress in consolidating with Shire Plc.
Kala Pharmaceuticals Inc. received a complete response letter from the U.S. Food and Drug Administration regarding the company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
Allergan Plc – which is being bought by AbbVie Inc. for $63 billion – beat second-quarter 2019 profit estimates and raised the company’s full-year revenue forecast, helped by demand for the dry eye drug Restasis and aesthetics product Juvederm.
Novartis is buying the projected blockbuster dry-eye drug Xiidra from Takeda Pharmaceutical for up to $5.3 billion.
Kala Pharmaceuticals Inc. announced that the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration FDA.
Dublin-based Allergan announced in 2016 plans to spend $200 million to expand the company’s manufacturing facility in Waco, Texas. That plan would have increased production capacity by more than 50 percent and created more than 100 jobs in the area.
The U.S. Food and Drug Administration approved Kala Pharmaceuticals Inc.’s treatment for reducing inflammation and pain following an eye surgery.
Sun Pharmaceutical Industries Ltd. received FDA approval for Cequa (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca.