News and Updates by the Food and Drugs Administration (FDA)
Lupin Limited, a global leader in the pharmaceutical industry, has announced it has secured tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application. This approval pertains to abacavir, dolutegravir, and lamivudine tablets […]
As the complexities of modern living escalate, there is a growing emphasis on comprehensive health and wellness as a means to sustain a high quality of life. In line with this endeavor, Amway India, a pioneer in health and wellness
In a landmark achievement within the global Ayurveda community, over 70 learners from upwards of 30 nations united to embark on an innovative 3-year Ayurveda, Siddha Veda education program. This significant milestone, orchestrated by the Ayushakti Academy of Ayurveda, was
Boston-based Myomo (NYSE:MYO) has announced the pricing of a $15 million underwritten common stock offering. The wearable exoskeleton company is releasing 3 million shares at $5 each. Buyers have a 30-day window to purchase up to an additional 450,000 shares
Myomo Sets $15 Million Stock Offering to Expand Workforce During Growth Phase Read More »
Smith+Nephew (NYSE:SNN) has confirmed that job roles will be phased out in Tennessee, in response to an inquiry from MassDevice today. “Our aim is to evolve into a more efficient and dynamic entity,” a representative conveyed via email. “While optimizing
Smith+Nephew Announces US Job Reductions Read More »
Field Medical announced it has secured the FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system. Additionally, this technology has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP), which promotes preliminary, consistent strategic interactions
FDA Recognizes Groundbreaking Pulsed Field Ablation Tech by Field Medical Read More »
Acutus Medical has opted for a strategic realignment, envisioning a significant workforce reduction of 70%. Dr. Shaden Marzouk, the chair of Acutus’ board, characterized this downsizing as “hard but necessary steps.” Despite these layoffs, the company is determined to meet
Acutus Medical Reduces Workforce to Focus on Medtronic Partnership Read More »
Eisai Co., Ltd. and Biogen Inc. have made an announcement regarding the approval from Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) for their humanized anti-soluble aggregated amyloid-beta (Aß) monoclonal antibody, “Leqembi” (lecanemab), designed for early Alzheimer’s disease
Mexican Authorities Grant Approval for Leqembi as an Early Alzheimer’s Disease Treatment Read More »
**Merus N.V., a company specializing in oncology and working on groundbreaking, comprehensive, multispecific antibodies (Biclonics and Triclonics), announced the FDA’s nod for Bizengri (zenocutuzumab-zbco).** This milestone marks the first approved therapy for adults with advanced unresectable or metastatic pancreatic adenocarcinoma
FDA Greenlights Merus’ Bizengri for Pancreatic and Lung Cancer Treatment Read More »
GSK plc, in collaboration with Medicines for Malaria Venture (MMV), has revealed that the World Health Organization (WHO) has granted prequalification status to tafenoquine, marking it as the first single-dose treatment aimed at preventing relapses of *Plasmodium vivax* (P. vivax)
GSK and MMV Unveil New Single-Dose Tafenoquine for P. vivax Malaria with WHO Recognition Read More »