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The FDA’s Fast Track designation is designed to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet

The conditional marketing authorisation is based on the recommendation of the European Medicines Agency (EMA) for use of the Covid-19 Vaccine Moderna for active immunisation to prevent Covid-19

Fujifilm stated that it is establishing the new manufacturing site to boost the growth of its biopharmaceutical contract development and manufacturing business (CDMO). The company’s subsidiary Fujifilm Diosynth

Under the deal, LakePharma will produce Akston’s adjuvanted Covid-19 vaccine candidate (AKS-452), which is slated to start phase 1/2 clinical testing later this month. LakePharma president and CEO

CURE is seeking approval of this product via the 505(b)(2) regulatory pathway to expedite the U.S. approval process. CUREfilm Blue utilizes the Company’s patented and proprietary fast-dissolving drug

The breakthrough therapy designation allows the combination therapy as a first-line treatment for people with metastatic NSCLC whose tumours have high PD-L1 expression with no EGFR or ALK

“Today’s authorization is a landmark moment in our company’s history and in the global fight against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This is the

“This is an important milestone for ARX788 that underscores the strong unmet medical need to develop new and effective treatment options for breast cancer patients whose tumors progressed

Arvelle Therapeutics is involved in the development of advanced solutions to treat patients suffering from central nervous system (CNS) disorders. The company is currently engaged in the development