Takeda

The agency extended the label for Takeda’s immune globulin infusion as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy.

FDA

The announcement comes just a month after Casgey was approved by the FDA in December 2023 to treat patients with sickle cell disease, when it became the first CRISPR gene editing therapy to reach the U.S. market.

Artificial intelligence, face

The healthcare industry is acutely aware of the elevated compliance concerns involved with artificial intelligence and machine learning, and its governing organizations are taking swift action to address these challenges. In fact, the latest guidelines proposed by international regulatory organizations such as the FDA, European Union (EU), and European Medicines Agency (EMA) are poised to reshape the lifesciences industry, especially for clinical trials.

Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.

Money

Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.

No longer on the periphery of the life sciences market, nonprofit groups are bridging the gaps in drug discovery and development.

FDA

After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.

AstraZeneca

The company said it has not seen any supply issues so far due to Red Sea shipping disruptions, a top executive told Reuters ahead of the World Economic Forum (WEF) on Monday.

female contraceptives, birth control

The current unmet needs in the female contraceptives market are similar to those that were present 10 years ago, according to GlobalData.

Merck

This approval marks the third indication for Keytruda in cervical cancer and the 39th indication for Keytruda in the United States.