Johnson & Johnson seeks US & EU approvals for Darzalex …
1 day ago · Johnson & Johnson announced the submission of regulatory applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in the US and Darzalex subcutaneous (SC) formulation in ...
Paratek Pharma announces positive top-line data from phase 2b …
1 day 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 ...
Aurobindo Pharma net profit grows 8.6% in Q2FY25
1 day ago · Aurobindo Pharma net profit grows 8.6% in Q2FY25: Our Bureau, New Delhi Monday, November 11, 2024, 10:45 Hrs [IST] Hyderabad-based Aurobindo Pharma has registered a growth of 8.6 per cent in net profit for the quarter ended September 30, 2024 at Rs. 816.95 crore as compared to Rs. 751.94 crore during the same period of previous fiscal year.
US FDA grants orphan drug & rare paediatric disease designations …
4 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 ...
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 ...
TopNews - Pharmabiz.com
6 days ago · 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.
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
Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
Friday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
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]
AstraZeneca to acquire clinical-stage biopharma company, Fusion …
Mar 20, 2024 · AstraZeneca to acquire clinical-stage biopharma company, Fusion Pharma for $2 billion: Cambridge, UK Wednesday, March 20, 2024, 11:00 Hrs [IST] AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs).