AstraZeneca Q2 Highlights: Profits Fall, COVID-19 Vaccine Sales Dip, Lifts Annual Sales Guidance
AstraZeneca Plc (NASDAQ:AZN) Q2 profits fell sharply on ballooning costs linked to its Alexion takeover. The net profit was down…
FDA Accepts AstraZeneca’s Submission For Low Breast Cancer Candidate Under Priority Review
The United States Food and Drug Administration (FDA) has accepted to review the supplemental Biologics License Application (sBLA) of AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo’s lead asset ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable
Europe’s CHMP Recommends Approving AstraZeneca’s Asthma, Neuromuscular Disorder Treatments
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca Plc’s (NASDAQ:AZN) Ultomiris (ravulizumab)…
AstraZeneca Announced Enhertu Granted Priority Review in the US for Patients with HER2-low Metastatic Breast Cancer
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative) breast cancer who have received a prior therapy in the metastatic set
AstraZeneca Announced Ultomiris Recommended for Approval in the EU by CHMP for the Treatment of Adults with Generalized Myasthenia Gravis
Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
AstraZeneca Announced Tezspire Recommended for EU Approval in Asthma
AstraZeneca's Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Apple, Meta, Pfizer Among Key Companies Reporting In The Week Ahead, As Earnings Pick Up Pace
Big tech earnings will flow in thick and fast in the upcoming week, providing more clarity on how supply chain disruptions and the macroeconomic malaise have impacted these companies.
The Daily Biotech Pulse: FDA Tentatively Approves Avadel’s Narcolepsy Drug, European Approval Broadens AstraZeneca’s Enhertu in Breast Cancer, Pharma Giants’ Earnings
Here's a roundup of top developments in the biotech space over the last 24 hours: