Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
FDA Extends Review Period for Applied Therapeutics’ Govorestat by Three Months Read More »
The Swiss contract manufacturer’s cash deal for Roche’s facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs.
What Lonza’s $1.2B Buy of Roche Biologics Plant Means for CDMO Market Read More »
Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
Gilead Wins Label Expansion for Vemlidy to Treat Hepatitis B Virus in Kids Read More »
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
BMS’ Zeposia Fails to Meet Primary Endpoint in Phase III Crohn’s Trial Read More »
Guardion Health Sciences, Inc. announced its financial results for the year ended December 31, 2023.
IASO Bio announced that China National Medical Products Administration has approved the Investigational New Drug application for Equecabtagene Autoleucel, a self-developed fully-human anti-B cell maturation antigen chimeric antigen receptor autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma patients who have undergone 1-2 lines of prior therapies and are refractory
Adlai Nortye Ltd. announced the appointment of Dr. Archie Tse as Head of Research & Development, reporting to Mr. Carsten Lu, CEO and Chairman of Adlai Nortye, effective March 29th, 2024.
Shanghai Junshi Biosciences Co., Ltd, announced its financial results for the full year of 2023 and provided corporate updates.
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company announced that the first patient in China has been dosed in the Phase 1b clinical study of the combination of InnoCare’s novel SHP2.
Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results.
