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.
Dizal seeks US FDA approval for sunvozertinib to treat relapsed or ...
3 days ago · Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally ...
Novo Nordisk announces positive results from phase 3 ESSENCE …
Nov 5, 2024 · Novo Nordisk, a leading global healthcare company, announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 ...
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
5 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.
Lilly's mirikizumab is first and only IL23p19 antagonist to report …
Oct 29, 2024 · Lilly's mirikizumab is first and only IL23p19 antagonist to report long-term, multi-year, sustained efficacy and safety data for both UC & Crohn's disease
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
Takeda’s vedolizumab receives US FDA approval to treat …
Apr 20, 2024 · Osaka, Japan. Saturday, April 20, 2024, 16:00 Hrs [IST] Takeda announced that the US FDA has approved Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) Entyvio. The subcutaneous administration of Entyvio was ...