US FDA approves Jazz Pharma’s Ziihera to treat adults with …
2 days ago · Jazz Pharmaceuticals plc announced the US Food and Drug Administration (FDA) accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC ...
Syngene embarks on evaluating the bioequivalence of an …
2 days ago · Syngene has embarked on evaluating bioequivalence of an injectable for type-2 diabetes and weight management. This was after a global pharma company was scouting for a partner to outsource its human pharmacological studies for semaglutide. The reference drug, Ozempic, was an anti-diabetes and anti ...
Novartis upgrades mid-term guidance and highlights deep …
2 days ago · Novartis announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. Previous guidance for +5% sales CAGR 2023-2028 was upgraded to +6%, driven by strong momentum of in-market growth drivers and upcoming launches, most of ...
Pharmanovia partners with Lindis Biotech to commercialise …
2 days ago · Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has announced the expansion of its oncology portfolio with a new licensing agreement for catumaxomab, for the treatment of malignant ascites ...
Pfizer’s Hympavzi receives European marketing approval to treat …
3 days ago · Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A (congenital factor VIII [FVIII] deficiency ...
Merck’s phase 3 trial of subcutaneous pembrolizumab with ...
3 days ago · Merck, known as MSD outside of the United States and Canada, announced positive topline results from the pivotal phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as ...
Late-breaking data reinforce long-term benefits of Abbott's …
4 days ago · Abbott, a global healthcare leader, announced late-breaking data for the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder to treat people with atrial fibrillation (AFib) who are at an increased risk of stroke. The new five-year findings demonstrate that Abbott's Amplatzer Amulet helps more ...
Azurity Pharma gets US FDA approval for Danziten tablets, the first …
Nov 16, 2024 · Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase ...
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 ...
PTC Therapeutics’ gene therapy, Kebilidi to treat AADC deficiency ...
Nov 15, 2024 · 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 …