Pfizer-BioNTech's Omicron-adapted COVID-19 Vaccine Gets Positive CHMP Opinion in EU

 The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age a...

September 04, 2023 | Monday | News
ENHERTU® Earns Dual Breakthrough Therapy Designations for HER2-Expressing Cancers in the U.S

Designations for Daiichi Sankyo and AstraZeneca's ENHERTU include patients with HER2 expressing metastatic solid tumors and HER2 positive metastatic colo...

September 04, 2023 | Monday | News
23andMe Granted New FDA Clearance to Report Additional BRCA Variants

510(k) clearance will allow 23andMe to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, prosta...

September 01, 2023 | Friday | News
Asieris Receives NMPA IND Approval for APL-1401 in Ulcerative Colitis

The study is a randomized, double-blind Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patie...

August 30, 2023 | Wednesday | News
EU Approves Roche's Evrysdi for Infants Under Two Months with SMA

Evrysdi available to treat people of all ages with SMA in the European Union, including babies from birth1 Approval is based on interim data from ongoin...

August 29, 2023 | Tuesday | News
AstraZeneca Calls for Review of Inflation Reduction Act's Impact on US Patients

To help protect access to medicines for cancer and rare disease patients, AstraZeneca  has filed a legal challenge to critical aspects of the drug pri...

August 28, 2023 | Monday | News
GE Introduces Vscan Air SL: Handheld Wireless Ultrasound for Quick Cardiac Assessments

With a dual-headed probe, the Vscan Air SL offers a sector array and a linear array on a single device which is ideal for switching between focused cardi...

August 28, 2023 | Monday | News
ADVENT Study Shows Success of FARAPULSE™ Ablation System

Boston Scientific Corporation (NYSE: BSX)  announced positive 12-month results from the pivotal ADVENT clinical trial of the FARAPULSE™ Pulsed F...

August 28, 2023 | Monday | News
Agilent Receives European IVDR Certification for Companion Diagnostic Assay

PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA® (pembrolizumab), Merck&r...

August 25, 2023 | Friday | News
FDA Approves Veklury® for Hepatic Impairment COVID-19 Treatment

Gilead Sciences, Inc. (Nasdaq: GILD)  announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) f...

August 25, 2023 | Friday | News
Turkey's Ministry of Health Approves Novo Integrated Sciences' IoNovo Iodine

Novo Integrated Sciences, Inc. (NASDAQ: NVOS) (the “Company” or “Novo”),  announced that its IoNovo Iodine product has been gr...

August 23, 2023 | Wednesday | News
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

Abrysvo is administered as a single dose injection into the muscle. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals...

August 22, 2023 | Tuesday | News
Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML

– Enrolled Patients May Continue Receiving Study Medicine – – Studies in Solid Tumors Unaffected – The FDA action follows the pre...

August 22, 2023 | Tuesday | Regulatory
VenusP-Valve Receives IDE Approval for Global Valve Trial, Elevating Chinese Solutions

DE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices...

August 21, 2023 | Monday | News

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