Boston-based Intarcia Therapeutics became the latest casualty of the FDA’s manufacturing standards. The agency has rejected Intarcia’s implanted diabetes drug/device, which company execs have long insisted is on a straight path to blockbuster sales.
Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
Medtronic has secured the US Food and Drug Administration (FDA) approval for its next generation spinal cord stimulator branded as Intellis platform for the management of certain forms of chronic intractable pain.
AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA/VENCLYXTO (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint.
The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants.
After committing billions of dollars to a new hepatitis C cocktail that had the potential to compete with the already deeply entrenched rivals on the market, J&J is calling it quits.
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today reported positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first in class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Chiesi's Holoclar, the first stem-cell therapy to be cleared by European regulators, has received a green light for use on the NHS in England and Wales to treat a rare sight condition.
Titan Pharmaceuticals’ stated today that their ropinirole implant, designed to treat the symptoms of Parkinson’s disease, was cleared by the FDA today as a new drug application.
A five-year strategic research collaboration between AstraZeneca and its global biologics research and development arm MedImmune and Ethris, a company focussed on mRNA-based therapeutics with specific expertise in pulmonary disease.
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