Takeda to seek approval of plaque psoriasis pill on Phase III trial data
Takeda’s once-daily oral plaque psoriasis (PsO) drug has met all its endpoints in two pivotal trials, with the company set …
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Eli Lilly’s oral GLP-1RA maintains weight loss from injectable drugs
Eli Lilly’s oral glucagon-like peptide 1 receptor agonist (GLP-1RA), orforglipron, has proven its efficacy as a maintenance therapy in patients …
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MHRA launches call for evidence on AI regulation in UK healthcare sector
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a call for evidence seeking input from the healthcare …
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J&J receives FDA approval for lung cancer therapy
Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), …
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FDA approves meningioma label warning on Pfizer’s contraceptive injection
The US Food and Drug Administration (FDA) has approved a label change to Pfizer’s injectable contraceptive, Depo-Provera (medroxyprogesterone acetate), which …
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BIOSECURE Act set for Trump’s signature after Congress approval
After years in regulatory limbo, the BIOSECURE Act looks set to be enacted into law, placing relationships between US and …
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EC approves Incyte’s Minjuvi combo for follicular lymphoma
The European Commission (EC) has approved Incyte’s Minjuvi (tafasitamab) in conjunction with lenalidomide and rituximab for adults with relapsed or …
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Alnylam plans $250m investment in Norton manufacturing facility, US
Alnylam Pharmaceuticals is set to invest $250m in the expansion of its facility in Norton, Massachusetts, US, to meet the …
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CDC ends universal newborn hepatitis B vaccine recommendations
The US Centers for Disease and Prevention (CDC) no longer recommends that all US newborns receive the hepatitis B vaccine, …
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GSK obtains FDA approval for Exdensur in severe asthma
GSK has secured approval from the US Food and Drug Administration (FDA) for its severe asthma add-on maintenance therapy, Exdensur …
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Harbour BioMed and BMS sign multi-specific antibody collab
Harbour BioMed and Bristol Myers Squibb (BMS) have signed a multi-year, worldwide strategic partnership and licence agreement focused on multi-specific …
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Precision medicine approaches needed in oncology to match evolving SoC
As the standard of care (SoC) for new drugs in oncology continues to improve, trials need to be designed with …
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INCOG reveals $200m injectable drug expansion in Indiana
Contract development and manufacturing organisation (CDMO) INCOG BioPharma Services has announced injectable drug manufacturing expansion at its Fishers facility in …
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Pharmaceutical Technology Excellence Awards 2025: Cellular Origins
Cellular Origins, a company enabling the manufacture of cell therapies at scale through a flexible, mobile robotic automation platform, has …
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States consider payment limits to curb prescription drug prices with PDABs
Four weeks into her pregnancy, Jessica Intermill sensed something was wrong when the pain in her fingers wouldn’t subside. What …
