Regulation

Dr. Reddy’s receives approval to conduct Phase 3 clinical trial for Sputnik V vaccine in India

Dr. Reddy’s Laboratories has announced that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India.

Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer

New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience
 

Pfizer’s XALKORI approved by FDA for ALK-positive anaplastic large cell lymphoma in children and young adults

Pfizer announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

Novartis gets FDA breakthrough therapy status for ligelizumab to treat chronic spontaneous urticaria

Novartis has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its ligelizumab (QGE031) to treat chronic spontaneous urticarial.

Bayer announces FDA accepts NDA and grants priority review for Finerenone for patients with CKD and T2D

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

GSK, MMV filing for Kozenis in paediatric populations with P. vivax malaria accepted by Australian TGA

GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.

Inversago Pharma receives rare paediatric disease designation from FDA for INV-101 to treat Prader-Willi Syndrome

Inversago Pharma, the peripheral CB1 blockade company, announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).

RedHill Biopharma’s RHB-204 granted FDA fast track designation for NTM disease

RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.

Moderna gets EC conditional marketing authorisation for Covid-19 mRNA vaccine

Moderna has secured conditional marketing authorisation (CMA) from the European Commission (EC) for mRNA vaccine called Covid-19 Vaccine Moderna.