Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
The U.S. Food and Drug Administration reported 1,171 generic drug approvals (935 full approvals and 236 tentative approvals) for fiscal year 2019, up from the previous all-time record total of 971 during 2018.
Noven Pharmaceuticals won approval from the U.S. Food and Drug Administration for the company’s transdermal schizophrenia patch.
The U.S. FDA approved Janssen’s Xarelto (rivaroxaban) for preventing blood clots in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
The U.S. Food and Drug Administration approved Clinuvel Pharmaceuticals Ltd.’s treatment for a rare inherited disorder that causes skin damage from exposure to light, sending the Australian drugmaker’s shares to a record high.
Novartis received approval from the U.S. Food and Drug Administration for the Swiss pharmaceuticals company’s drug Beovu to treat a cause of vision loss.
The U.S. FDA approved a bone-building drug from Pfenex Inc. to treat osteoporosis in certain patients at high risk for fractures, marking the company’s first commercial product.
The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.
Janssen’s Invokana Becomes First Drug Approved in 20 Years to Slow Diabetic Kidney Disease
Approvals, Cardiovascular Deaths, Clinical Studies, Diabetic Kidney Disease, End-Stage Kidney Disease, FDA, FDA/Regulatory, Heart Failure, Kidney Disease Progression, Kidney Functioning, New Indications, SGLT2 Inhibitors, Type 2 DiabetesInvokana won U.S. approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
The U.S. Food and Drug Administration approved Janssen’s Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
