Rhythm forced to wait for Imcivree expansion as FDA delays decision
The US Food and Drug Administration (FDA) has extended the review period for expanded approval of Rhythm Pharmaceuticals’ Imcivree (setmelanotide) …
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J&J’s Darzalex gains first FDA approval in smouldering multiple myeloma
Johnson & Johnson’s (J&J) blockbuster oncology asset, Darzalex Faspro (daratumumab and hyaluronidase-fihj) has gained US approval in smouldering multiple myeloma …
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Trump hits long-term pledge as US prices of weight loss drugs slashed
President Donald Trump achieved one of his key targets in the healthcare sector, following agreements with Eli Lilly and Novo …
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Abzena and Mabqi partner for drug development solution
Abzena and Mabqi have announced a partnership integrating antibody discovery capabilities with development and manufacturing services for a drug development …
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Alvotech and Advanz announce MHRA marketing authorisations for Gobivaz
Alvotech and Advanz Pharma have announced the receipt of marketing authorisations from the UK Medicines and Healthcare products Regulatory Agency …
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J&J’s Caplyta wins MDD approval to extend revenue horizon
Caplyta (lumateperone) has scored a label extension into the depression setting, underscoring the belief Johnson & Johnson (J&J) saw in …
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Former blockbuster Linzess grows label with paediatric IBS-C approval
The US Food and Drug Administration (FDA) has approved Linzess (linaclotide) as the first treatment for children living with irritable bowel …
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Novo Nordisk’s oral Wegovy reduces cardiovascular risk factors in obesity
Novo Nordisk’s oral therapy Wegovy (semaglutide) reduced cardiovascular risk factors in the Phase III OASIS 4 trial. Being used by the …
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Cencora to invest $1bn in US pharma distribution network
Cencora is set to invest $1bn by 2030 for expanding its US pharmaceutical distribution network, adding resilience and capacity to …
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Leukogene Therapeutics gains FDA ODD status for M2T-CD33
Leukogene Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for M2T-CD33 (LTI-214), …
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Novo Nordisk latest outlook trim shows “quick momentum loss”
Novo Nordisk has cut its outlook for 2025 as lower expectations for glucagon-like peptide-1 receptor agonists (GLP-1RA) continue to hit …
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Agentic, deeply embedded AI constitutes the “next wave” of tech
Artificial intelligence (AI) has become a key buzzword in the pharmaceutical industry, with most, if not all, companies looking to …
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Avant and SGAustria form JV to develop diabetes therapy
Avant Technologies and SGAustria have announced a joint venture (JV) and licence agreement to advance a therapy for diabetes using …
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The latest regulatory updates affecting parenteral packaging
Regulations are the cornerstone of the pharmaceutical industry, with parenteral packaging often an area of scrutiny due to its importance …
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Innovation meets convenience: Redefining lyophilized drug delivery for patients
Over the past few decades, the pharmaceutical industry has seen a steady shift toward parenteral self-administration and home-based care. As …
