The complex regulatory landscape for biological drug products presents opportunities in mastering Chemistry, Manufacturing, and Controls (CMC) requirements, especially for varying molecule types. This ...

THE electric vehicle industry's most pressing challenge remains battery safety, particularly the risk of thermal runaway — a catastrophic failure mode where batteries overheat and potentially ignite.

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Biogen Inc.’s (NASDAQ: ...

The FDA letter requested that a technical information update be included in the Chemistry Manufacturing and Controls (CMC) ...

The investment was made via 60 crore partly paid-up equity shares of face value Rs 10 each, issued at par. Of this, Rs 5 per ...

The U.S. Food and Drug Administration has declined to approve a higher-dose version of Biogen's drug for a rare genetic ...

Biogen was asked to update its application to the U.S. Food and Drug Administration for a high dose regimen of nusinersen to treat spinal muscular atrophy. The regulatory agency told Biogen to update ...

Biogen is working with regulatory authorities around the world to advance the high dose regimen as an additional dosing option for people living with SMA. The high dose regimen of SPINRAZA (nusinersen ...

Stellantis has developed a new EV battery pack configuration that eliminates the separate power electronics module and ...

We develop cutting-edge software and AI solutions for small molecule design, optimization and data analysis. Our mission is ...

What if we could get clean electricity more cheaply and protect the environment at the same time? A team of researchers in ...

Biology class just got a lot more engaging for students at Arizona State University Polytechnic, where students are using virtual reality to explore it through immersive lessons that apply real-world ...