With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.

Sumitovant offered $22.75 per share in cash, valuing Myovant at $2.4bn total, to acquire what it does not hold as a result of its 2019 agreement to buy majority shares of five Roivant companies. 

The US FDA has labelled a recall of several hundred components of the LifeSPARC circulatory support system from LivaNova as class I, the agency’s most serious recall designation.

After highlighting oncology drugs pegged to make a splash next year with the help of Biomedtracker, Scrip takes a look at seven potential blockbusters across a range of therapeutic areas including neurology, dermatology and blood disorders slated for approval next year.