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The FDA on Tuesday approved the use of Vanda Pharmaceuticals’ atypical antipsychotic Fanapt (iloperidone) for the treatment of manic or mixed episodes in adult patients with bipolar I disorder.
Multiple doses of Eli Lilly’s top-selling diabetes medication Mounjaro (tirzepatide) will be in short supply through April 2024, according to the FDA’s database for drug shortages and discontinuations.
Acorda Therapeutics on Monday announced that it has voluntarily filed for bankruptcy and is seeking Chapter 11 protections to facilitate the orderly transfer of its assets and the winding down of its business operations.
Verve Therapeutics has suspended enrollment in the Phase Ib Heart-1 study evaluating its lead gene editing program VERVE-101 following a serious adverse event, the company announced Tuesday.
The U.S. Court of Appeals for the Federal Circuit on Monday ruled in favor of Teva Pharmaceuticals and Viatris, finding that the final Johnson & Johnson patent over its schizophrenia drug Invega Sustenna is invalid.
Eiger BioPharmaceuticals on Monday announced that it has voluntarily filed for bankruptcy and has kicked off the process of selling its assets and winding down the company’s operations.
AstraZeneca announced Monday that it has secured FDA approval for an add-on to its blockbuster rare disease franchise, providing a potential differentiator as it tries to hold off competition from Novartis, Roche, and biosimilars.
2023 was a banner year for cell and gene therapy, with seven FDA approvals, according to the Alliance for Regenerative Medicine. And the pace doesn’t appear to be slowing at all as the second quarter of this year gets underway. The advocacy group is anticipating an even bigger year for the CGT space in 2024, with a potential 17 approvals in the U.S. and EU combined, according to ARM’s annual Cell & Gene State of the Industry Briefing in January.
The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.
