Legal
A federal court sided in favor of Vanda Pharmaceuticals in its Freedom of Information Act case against the FDA regarding the CRL for its sleep drug label expansion.
Citing reports of “alarming toxicity” among other accusations, short-seller Scorpion Capital will file a Citizen’s Petition with the FDA to have its approval of Wakix withdrawn.
CytoDyn has spent the past two years under siege. In an exclusive interview, Cyrus Arman, president, told BioSpace how the company is looking to turn the page.
Senate Bill 1162, a law requiring employers to include pay ranges in all job advertisements, went into effect in California January 1. Here’s how employers are responding.
The Pregnant Workers Fairness Act (PWFA) has been praised by many in the life sciences who see it as a step forward in protecting the rights of pregnant employees.
Trade secrets litigations and disputes have been on the rise in recent years, and given the FTC’s recent proposal to ban all non-compete agreements nationwide, the trend is likely to continue.
Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior.
A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), is requesting that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi (enzalutamide), a prostate cancer therapeutic.
The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.
Amgen’s Repatha may cause cardiac harm, according to a reassessment of the biologic’s late-stage trial data.
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