Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...

Iterum Therapeutics (($ITRM)) has held its Q4 earnings call. Read on for the main highlights of the call. During Iterum Therapeutics’ latest ...

Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

Supernus Pharmaceuticals' FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The Food and Drug Administration approved Novo Nordisk’s Ozempic as the first GLP-1 treatment option for people with type 2 ...

The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...

The FDA on Tuesday signed off on Supernus Pharmaceuticals’ apomorphine hydrochloride injection—to be marketed under the brand ...

A group of Senators has warned the FDA about an ad expected to air during Sunday’s big game that they believe misleads ...

African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...