President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics ...

Inspired by the world's great Lego Masters, Arovella is taking a brick-by-brick approach to building its unique cancer immunotherapy program.

Nearly 600 attendees learned about life sciences industry trends and heard from 93 presenting biotechnology companies at ...

The FDA has issued a complete response letter (CRL) to Merck & Co's gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close the gap with ...

The French pharma group has just been granted a fast-track designation from the FDA for a preclinical-stage mRNA-based vaccine candidate that is due to start a phase 1/2 trial in the coming days ...

Priorix was first launched in Europe almost a quarter of a century ago by GSK's predecessor SmithKline Beecham, and is a combination measles, mumps and rubella (MMR) vaccine now cleared by the FDA ...

Japanese drugmaker Takeda has suffered a blow to its late-stage pipeline, after the FDA rejected its marketing application for TAK-721, a drug candidate that is trying to be the first approved ...

In the space of four days, the number of FDA-approved therapies for ultra-rare genetic disorder Niemann-Pick disease has gone from zero to two, transforming the prospects for patients. IntraBio's ...

The FDA has approved Amgen’s cheaper Humira biosimilar, Amjevita, but launch could be delayed by up to three years after AbbVie launched a legal challenge earlier this month.

There are other TSLP-targeting drugs in clinical development for COPD, including Uniquity Bio’s solrikitug, which has been cleared by the FDA to start phase 2 trials.

Novo Nordisk applied to the FDA for approval of semaglutide in obesity in December, using an acquired priority voucher to speed up the review time. Looming on the horizon is Lilly's tirzepatide ...

Another competitor is Pfizer's JAK3/TEC inhibitor Litfulo (ritlecitinib), which was approved by the FDA in 2023. Incyte's infringement lawsuit is claiming that Sun Pharma's drug infringes a US ...