Press Releases

Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. "RSV poses a serious heal

Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. “We are very pleased that the feedback from regulatory authorities has allowed us to take sub

AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients wi

Biogen Inc. will host a virtual investor seminar today at 10:00 a.m. ET focused on the potential of the investigational drug felzartamab in rare kidney diseases and the potential to target CD38 for a range of immune-mediated diseases. Since 2023, Biogen has worked to transform its portfolio, building upon its legacy in multiple sclerosis and neuroscience to expand in immunology and rare diseases, where the company has well-established global development commercialization capabilities.

Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved XIFYRM™ (meloxicam injection), an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing. XIFYRM is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. XIFYRM provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of

Sanyou Biopharmaceuticals, a leading Shanghai-based high-tech biopharmaceutical company specializing in biologics R&D today announced the signing of a strategic cooperation agreement with Medicovestor, Inc., a New York-based biotechnology company pioneering first-in-class chemoimmunotherapy antibody-drug conjugates (ADCs). The agreement, officially signed on June 6, brings together Medicovestor's proprietary ADC platforms—ADoBind, a novel dimeric antibody architecture,

Microbot Medical Inc, developer of the innovative LIBERTY Endovascular Robotic System, today announced the continued expansion of its commercial team in preparation for the anticipated U.S. launch of the LIBERTY System, which is projected during the third quarter of 2025. The Company remains actively engaged with the U.S. Food and Drug Administration (FDA), with a 510(k) decision now expected during the third quarter of this year. This updated FDA decision timeline remains within the FDA&rsqu

RenaissThera Private Limited (“RenaissThera”), a Bengaluru-based biotechnology company, announced a major milestone in its obesity drug discovery program targeting the glucose-dependent insulinotropic polypeptide receptor (GIPR). GIPR, an incretin receptor, is a validated target for peptide-based parenteral therapies where both stimulation and inhibition has shown efficacy in treating obesity and its co-morbidities. RenaissThera is developing novel, oral small molecules, both agon

Merck known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a ty

Alvotech a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy’s Laboratories Ltd, today announced that the companies have entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda® (pembrolizumab) for global markets. Keytruda® (pembrolizumab) is indicated for the treatment of numerous cancer types