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Regulatory

Drug Approvals in 2023

Drug Approvals in 2023

The year 2023 has seen a number of important drug approvals, both for new drugs and for new indications for existing drugs. Here are some of the most notable approvals: * Dostarlimab: Dostarlimab is a first-in-class drug that has been approved for the treatment of advanced rectal cancer. Dostarlimab is a

State attorneys general urge Apple to strengthen privacy protections for information about reproductive health.

State attorneys general urge Apple to strengthen privacy protections for information about reproductive health.

Attorneys General from ten states are urging Apple to enact more privacy safeguards for third-party apps that gather information on users' reproductive health. Following the Dobbs decision by the US Supreme Court overturning Roe v. Wade, a number of state attorneys general expressed privacy concerns in a letter (PDF) to

Recent Approval for Ublituximab

Recent Approval for Ublituximab

TG's first-in- class lymphoma med ukoniq was pulled from approval by the FDA last November, but now TG has won another approval. TG's anti-CD20 treatment, Briumvi, will be available beginning in the first quarter of 2023. TG Therapeutics Inc. Recently won approval for its ublituximab drug for people with relapsing

Proposed regulation intends to make it simpler for providers to care for substance users

Proposed regulation intends to make it simpler for providers to care for substance users

A proposed regulation intends to make it simpler for providers to coordinate care among clients suffering from substance usage condition (SUD) by balancing privacy defenses for those patients' medical records. The notification of proposed rulemaking, launched Monday by the Department of Health and Human Services (HHS), pursues a balance in