Regulatory
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.
Monday morning, Nuvation Bio announced that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I dose escalation study of NUV-422.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report published by The Wall Street Journal.
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
In an overwhelming vote of support, the U.S. House of Representatives approved the creation of a new department within the National Institutes of Health that is focused on biomedical innovation.
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.
PRESS RELEASES