US FDA grants 510(k) clearance to Bayer’s MEDRAD Centargo CT …
1 day ago · Berlin. Saturday, November 9, 2024, 09:00 Hrs [IST] Bayer, a global enterprise with core competencies in the life science fields of health care and nutrition, announced 510 (k) clearance from the US Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System, an innovative multi-patient injector that drives workflow ...
Dizal seeks US FDA approval for sunvozertinib to treat relapsed or ...
23 hours 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 ...
US FDA grants orphan drug & rare paediatric disease designations …
2 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 ...
Novo Nordisk announces positive results from phase 3 ESSENCE …
5 days ago · 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 ...
CytoDyn gets US FDA nod to begin phase II oncology trial of …
3 days ago · CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that it has received clearance from the US FDA to commence its phase II oncology trial. The study will evaluate the efficacy of leronlimab in patients ...
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 ...
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
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 ...
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 ...
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).