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US FDA clears RiVive nasal spray for OTC use in opioid overdose
The FDA approval was based on the results from a Harm Reduction’ study that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product
Curium receives EC’s marketing authorisation for Pylclari in EU
Pylclari is an 18F-PSMA positron emission tomography (PET) tracer that detects prostate-specific membrane antigen (PSMA) positive lesions with PET in adults with prostate cancer
SYFOVRE Continued to Demonstrate Increasing Treatment Effects Over 30 Months in Patients with Geographic Atrophy (GA)
SYFOVRE reduced nonsubfoveal GA lesion growth by up to 45% between Months 24-30 compared to projected sham in the GALE long-term extension study
Celularity, Verséa sign distribution agreement for Biovance and Biovance 3L Ocular
Under the exclusive US commercialisation agreement, Verséa Ophthalmics will distribute Celularity’s ophthalmic products for the treatment of ocular surface disease and ocular surgical applications
Lilly’s tirzepatide met primary and key secondary objectives in two Phase 3 studies
For the efficacy estimand, participants in both trials who started taking GIP receptor after an intensive lifestyle intervention or who maintained taking tirzepatide saw a mean weight loss of up to 26.6%
Belite Bio Doses First Subject in Pivotal Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant for GA
Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in subjects with Stargardt Disease and Geographic Atrophy in advanced Dry Age-related Macular Degeneration
SIGA Announces US Government Procurement Orders of Approximately $138m for Oral and IV TPOXX
Exercise of Procurement Options of Approximately $113m for Oral TPOXX and Approximately $25m for IV TPOXX under Current Contract reflects continuing global action to enhance smallpox preparedness
UK MHRA reviews Novo’s Ozempic and Saxenda for suicidal thoughts
The review of the safety data was triggered following reports of suicidal thoughts and self-injury in people using Ozempic and Saxenda drugs, Reuters reported
Merck, Moderna start Phase 3 study of V940-Keytruda combo for melanoma
V940-001 trial is a randomised, double-blind, placebo- and active-comparator-controlled study with a goal to assess the safety and effectiveness of the V940/ Keytruda combination against Keytruda alone in melanoma patients
Takeda scraps TAK-994 programme after safety concerns in narcolepsy study
The TAK-994-1501 Phase 2 study assessed the safety and efficacy of the OX2R agonist in narcolepsy type 1 patients, aged 18 to 65 years