(Reuters)—Amgen Inc. and UCB SA no longer expect their experimental osteoporosis drug to win U.S. approval this year after a higher rate of serious heart-related side effects were observed in a late-stage clinical trial. The drug, romosozumab, which would be sold under the brand name Evenity if approved, is awaiting an approval decision by the…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
FDA Approves Oral Methotrexate; Plus Restrictions for 2 Analgesics in Children
The FDA has approved a new formulation of methotrexate designed as an oral solution for pediatric patients. The agency has also recently introduced age restrictions for codeine and tramadol for children under age 12, citing their risks for slowed or difficult breathing and death…
FDA to Review Immediate-Release Oxycodone; Plus NICE Recommends Secukinumab
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
Baricitinib Approval Stalls; Plus No REMS for Erythropoiesis-Stimulating Agents
The FDA has declined to approve baricitinib to treat rheumatoid arthritis, citing the need for more data on dosing and safety…
Brodalumab Approved for Plaque Psoriasis, Plus Baricitinib Effiicacy Studied for RA
Brodalumab Approved for Plaque Psoriasis The U.S. Food and Drug Administration has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL‑17).1,2 Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other…
FDA Drug Labeling, Approval Process Help Minimize Lawsuits Against Pharmaceutical Companies
Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
The Risks of Opana Extended Release
In March, an FDA advisory committee voted that the risks of Opana ER to public health outweigh its benefits as a chronic pain treatment…
FDA Warns Mylan Over Quality Concerns at India Facility
(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…
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