Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market.

Sep. 25, 2024 — Almost everyone knows about HIV. Fewer people know about its relative, HTLV-1. However, HTLV-1 can cause serious illnesses, including cancer. To develop ways to combat this virus ...

Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination ...

In the INAVO120 trial, Itovebi added to Pfizer's Ibrance and fulvestrant doubled progression-free survival versus Ibrance and fulvestrant alone.

The US FDA approved Itovebi in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex for certain breast cancer ...

With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K ...

The Food and Drug Administration (FDA) approved Genentech's Itovebi (inavolisib), in combination with palbociclib (Ibrance) ...

Novartis' Piqray/Vijoice (alpelisib) is the only PIK3CA inhibitor to have reached the market for breast cancer, having been ...

Itovebi is supplied as a tablet in 2 dosage strengths: 3mg and 9mg. Patients should be selected for treatment based on the presence of 1 or more PIK3CA mutations in plasma specimens. The FDA has ...

Itovebi — also known as inavolisib — is designed to be given with drugs from Pfizer Inc. and AstraZeneca plc to treat adults ...

The FDA approved the PI3K-pathway inhibitor inavolisib (Itovebi) for use in combination with palbociclib (Ibrance) and ...

As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a ...