The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures … (click PDF to read more)FDA News ReleaseMolecular & Cellular Pharmacology
The FDA on Monday approved an osteoporosis medication — PF708 — developed by Pfenex under the 505(b)(2) regulatory pathway as a follow-on biologic to teriparatide injection, according to a press release from the company. PF708 is indicated for treatment of osteoporosis...
Endocrine Today | Pfizer announced that the FDA has approved its new treatment for moderate-to-severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis in women with a uterus, ...
Celltrion said Friday it submitted a marketing authorization application to the U.S. FDA for CT-P41, a biosimilar referencing Prolia (denosumab), aimed at treating osteoporosis and other related diseases. Prolia is an osteoporosis treatment developed by the multinational pharmaceutical giant Amgen. Its...
Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined...
Denosumab was originally approved under another trade name, Prolia, in June 2010. Prolia is indicated to treat postmenopausal women with osteoporosis who are at high risk for bone fractures. Xgeva is administered using a higher dose and with more frequent dosing than Prolia. Denosumab has a differ...
October 13, 2010 — Bisphosphonates approved for the treatment of osteoporosis will now bear a label warning about the possible increased risk for 2 types of atypical femur fractures, the US Food and Drug Administration (FDA) announced today. One type of break, subtrochanteric femur fracture, ...
(5.2) ? Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosisrelated fractures of the hip, wrist or spine. (5.3) ? Hypomagnesemia: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.4) --- ADVERSE REA...
Approved for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who havefailedor areintolerant toother available osteoporosis therapies. ...
Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. today announced that the FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to