Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Bayer, Beigene, Boehringer Ingelheim, Hope, Myovant, Passage.
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Futura, Genentech, Mustang, Precigen.
As expected – and well ahead of the Aug. 20 PDUFA date – Bothell, Wash-based Seattle Genetics Inc. (Seagen) won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chi-Med, Everest, Redhill, Seattle Genetics.
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
HONG KONG – South Korean biopharmaceutical company Kolon Tissuegene Inc. got a new lease on life as the U.S. FDA lifted the hold on the phase III trial for its lead candidate, Invossa-K (Invossa), for the treatment of osteoarthritis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai.
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