AstraZeneca PLC’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, after the FDA issued a complete response letter for the supplemental biologics license application. The… read more.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial,… read more.
Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas… read more.
NICE (UK): Danicopan (Voydeya) from Alexion/AstraZeneca, is recommended, as an add-on to ravulizumab or eculizumab as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults who have… read more.
AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 13th annual IDWeek in Los Angeles, California, from 16-19 October 2024. The Company will highlight… read more.
Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk… read more.
FluMist has been approved in the US as the only self-administered influenza vaccine. FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49… read more.
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for… read more.
AstraZeneca’s Fasenra (benralizumab) has been approved in China by the country’s National Medical Products Association (NMPA) for the maintenance treatment of patients 12 years of age and older… read more.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive… read more.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a review of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment… read more.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.
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