PTC Therapeutics’ gene therapy, Kebilidi to treat AADC deficiency ...
19 hours ago · Warren, New Jersey. Friday, November 15, 2024, 10:00 Hrs [IST] PTC Therapeutics, Inc., a global biopharmaceutical company, announced the US Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency, the first …
AstraZeneca to invest $3.5 billion in R&D and manufacturing in US
2 days 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 …
2 days 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 ...
Caliway’s drug molecule CBL-514 to treat Dercum’s disease …
1 day ago · Caliway has completed a CBL-514 phase 2 study (CBL-0201DD, NCT05387733) for Dercum’s disease in 2023. The study results demonstrated that after administrating CBL-514 treatment, 64.5% of painful lipomas showed a dimension reduction of more than 50%, and 38.7% of painful lipomas showed complete clearance, with pain being reduced by 4.7 points.
US FDA grants breakthrough therapy designation to Johnson
2 days 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 …
2 days 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 ...
Johnson & Johnson seeks US & EU approvals for Darzalex …
4 days 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 ...
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 ...
Pfizer’s Hympavzi receives US FDA approval to treat adults and ...
Oct 14, 2024 · Pfizer’s Hympavzi receives US FDA approval to treat adults and adolescents with haemophilia A or B without inhibitors: New York Monday, October 14, 2024, 18:00 Hrs [IST]
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 ...