Janssen announces U.S. FDA approval of Invega Hafyera
Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months
Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months
JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis
The drug is also intended for the treatment of glioblastoma multiforme
The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit
This is Enzene Biosciences third biosimilar to be approved
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
The clinical research organisation located in Hyderabad is a USFDA inspected facility
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
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