Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
KnipBio announced that its patent titled Methylotrophs for Aquaculture and Animal Feed has been approved for grant by the European Patent Office.
The FDA’s latest approval for Darzalex is based on results from the Phase III CASSIOPEIA trial that showed the addition of Darzalex to VTd before and after ASCT resulted in deeper responses in patients with the blood cancer.
AbbVie’s Mayvret won expanded approval from the U.S. Food and Drug Administration to shorten the one-daily treatment duration from 12 to eight weeks in treatment-naïve hepatitis C patients without cirrhosis and with compensated cirrhosis.
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration has approved JYNNEOS™ for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
US FDA 510(k) clearance paves the way for an innovative orthopedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes 1-3
Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.
Ergomed plc, a company focused on providing specialised services to the global pharmaceutical industry, announces its unaudited interim results for the six months ended 30 June 2019.
Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), part of the of the European Medicines Agency (EMA), recommended an update to marketing authorizations of approved interferon beta treatments, including PLEGRIDY® (peginterferon beta-1a) and AVONEX® (interferon beta-1a), to remove pregnancy contraindications and, where clinically needed, to allow use during pregnancy and breastfeeding in women with relapsing multiple sclerosis (MS).
Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC regardless of extent of disease