Drug

EMA's CHMP Backs Indication Extension for Johnson & Johnson's TALVEY – Talquetamab Combination Moves Toward Earlier‑Line Relapsed/Refractory Multiple Myeloma
CancerJ&J

EMA’s CHMP Backs Indication Extension for Johnson & Johnson’s TALVEY – Talquetamab Combination Moves Toward Earlier‑Line Relapsed/Refractory Multiple Myeloma

Johnson & Johnson (J&J; NYSE: JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication…

FDA Approves Roche's Enspryng for Thyroid Eye Disease – Satralizumab Becomes First and Only At‑Home Subcutaneous TED Treatment

FDA Approves Roche’s Enspryng for Thyroid Eye Disease – Satralizumab Becomes First and Only At‑Home Subcutaneous TED Treatment

FDA Approves Viatris's RYZUMVI for Presbyopia – Phentolamine Ophthalmic Solution 0.75% Adds Age‑Related Vision Indication to Existing Mydriasis Label

FDA Approves Viatris’s RYZUMVI for Presbyopia – Phentolamine Ophthalmic Solution 0.75% Adds Age‑Related Vision Indication to Existing Mydriasis Label

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Luye's LY03017 Wins FDA Nod for Psychosis Trials in Alzheimer's and Parkinson's
Clinical trial approval / initiationHKG: 2186

Luye’s LY03017 Wins FDA Nod for Psychosis Trials in Alzheimer’s and Parkinson’s

Biokin's iza-bren NDA Accepted for Nasopharyngeal Carcinoma, Advancing Bispecific ADC
ADC / XDCBiokin Pharmaceutical

Biokin’s iza-bren NDA Accepted for Nasopharyngeal Carcinoma, Advancing Bispecific ADC

Bayer's HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer
BayerCancer

Bayer’s HYRNUO Wins FDA Approval for HER2-Mutated Lung Cancer

Pien Tze Huang's PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient
Clinical trial approval / initiationPien Tze Huang Pharmaceutical

Pien Tze Huang’s PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient

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