AstraZeneca to invest $3.5 billion in R&D and manufacturing in US
1 day ago · Wednesday, November 13, 2024, 09:00 Hrs [IST] AstraZeneca, a global, science-led biopharmaceutical company, announces $3.5 billion of capital investment in the United States focused on expanding the company’s research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new ...
AstraZeneca, Daiichi Sankyo seek US FDA’s accelerated approval …
1 day ago · AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) non-small cell lung ...
US FDA grants breakthrough therapy designation to Johnson
22 hours ago · Johnson & Johnson announced that the US Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease with high prevalence, for ...
Boehringer Ingelheim and MTM Vision join forces to combat …
1 day ago · Boehringer Ingelheim and MTM Vision join forces to combat vision loss from diabetes. Ingelheim, Germany. Wednesday, November 13, 2024, 10:00 Hrs [IST] Boehringer Ingelheim and the Mary Tyler Moore Vision Initiative (MTM Vision) jointly announce the start of a long-term collaboration as Boehringer becomes the first pharmaceutical company to join ...
Paratek Pharma announces positive top-line data from phase 2b …
2 days ago · Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for serious diseases, announced top-line results from its phase 2b study of oral omadacycline in adult patients with Nontuberculous ...
US FDA grants orphan drug & rare paediatric disease designations …
5 days ago · Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the United States (US) Food and Drug Administration (FDA) granted Orphan Drug Designation and Rare Paediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular ...
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Nov 7, 2024 · Pharmabiz.com - India's most comprehensive online pharma news service. It provides updates on Indian pharma industry, allied sectors like hospitals & diagnostic services,pharma tenders, pharma projects, pharma export & import, pharma laws & documents, pharma policies, pharma events, pharma company profiles, pharma studies, pharma marketing.
US FDA grants accelerated approval to Novartis’ Scemblix for adult ...
Oct 31, 2024 · Novartis announced that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP). The accelerated approval is based on major ...
Novo Nordisk’ Wegovy gets US FDA approval for cardiovascular …
Mar 11, 2024 · Novo Nordisk’ Wegovy gets US FDA approval for cardiovascular risk reduction in people with overweight or obesity and established CVD: Bagsværd, Denmark
US FDA accepts and granted Priority Review status to …
Aug 16, 2024 · US FDA accepts and granted Priority Review status to AstraZeneca’s sBLA for Imfinzi to treat patients with limited-stage SCLC: Cambridge, UK Friday, August 16, 2024, 16:00 Hrs [IST]