Shares of Sarepta Therapeutics Inc. plunged 14 percent after the U.S. health regulator, in an unexpected move, declined to approve the drugmaker’s newest treatment for a muscle-wasting disorder.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.
AbbVie’s Rinvoq was approved by the FDA for treating adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
Shriners Hospitals for Children Announces New Medical Device for Scoliosis Treatment Approved by FDA
A new medical device for treating scoliosis – curvature of the spine – received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine.
The U.S. Food and Drug Administration approved Celgene Corp.’s Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis.
The FDA approved Roche’s personalized cancer treatment Rozlytrek, which targets tumors with specific genetic mutations, irrespective of where in the body the disease started.
Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.
The FDA proposed new health warnings for cigarette packages and ads due to small size and lack of an image in current warnings.
The U.S. Food and Drug Administration approved TB Alliance’s treatment for drug-resistant tuberculosis as part of a three-drug combination regimen called BPaL.