Pharma News, 2024

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to bemdaneprocel, a cell therapy BlueRock Therapeutics, a subsidiary o...

Johnson & Johnson (J&J) has announced it has entered into a definitive agreement with Numab Therapeutics to acquire its subsidiary, Yellow Jersey Therapeutics (YJT), expanding its immu...

Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological ...

FDA announced on May 28, 2024 that it has approved Amgen's Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) for the treatment of paroxysmal n...

Researchers have developed a new antibiotic that reduced or eliminated drug-resistant bacterial infections in mouse models of acute pneumonia and sepsis while sparing healthy microbes in the mouse gut...

The FDA has approved clonidine hydrochloride (Onyda XR; Tris Pharma), a once-daily oral treatment for attention deficit hyperactivity disorder (ADHD) as a monotherapy or adjunctive the...

Japanese company Asahi Kasei has made a public cash offer for the acquisition of all shares in the Swedish drugmaker Calliditas for Skr11.16bn ($1.04bn). The deal would involve the purchase of...

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of Sarclisa (isatuxim...

Eli Lilly has announced a substantial increase in its manufacturing investment at its site in Lebanon, Indiana, US, committing an additional $5.3bn funding to enhance active pharmaceutical ingredients...

Clear guidance on how and when to conduct health technology assessments (HTAs) of biosimilars is needed due to differences in perception of HTAs' role in the biosimilar space for authoriti...

The South Korean Ministry of Food and Drug Safety (MFDS) has granted approval for Eisai and Biogen’s LEQEMBI (lecanemab) for use in adults with mild cognitive impairment due to mild ...

Novartis  presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist...