Regulation - Approvals

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.

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.

Roche gets FDA breakthrough therapy status for tiragolumab plus Tecentriq

Roche has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for tiragolumab plus Tecentriq (atezolizumab) to treat PD-L1-high non-small cell lung cancer (NSCLC).

Israeli Ministry of Health authorises Covid-19 vaccine Moderna for use in Israel

Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel.

FDA grants ARX788 fast track designation for HER2-positive metastatic breast cancer

Ambrx announced that the US Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting.