Approvals

USFDA awards Breakthrough Therapy designation to Novartis’ asciminib

Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).

USFDA approves Breyanzi, new CAR T Cell therapy for adults

Global biopharmaceutical company Bristol Myers Squibb (BMS) has received  US Food and Drug Administration (USFDA) approval for its new CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).

AstraZeneca secures conditional marketing authorisation for Covid-19 vaccine in Europe

AstraZeneca has secured a conditional marketing authorisation for its Covid-19 vaccine in the European Union (EU) for active immunisation in individuals aged 18 years and above.

AstraZeneca secures China approval for treating mild asthma with Symbicort Turbuhaler

AstraZeneca announced that it has secured regulatory approval from China’s National Medical Products Administration (NMPA) for Symbicort Turbuhaler, an anti-inflammatory reliever to relieve symptoms of mild asthma.

UAE gives approval for use of Sputnik V vaccine to combat Covid-19

The Russian Direct Investment Fund (RDIF) has announced that the UAE Ministry of Health and Prevention (MOHAP) has given approval for the use of the Russian Sputnik V vaccine to combat Covid-19 pandemic.

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.