news

Jan 25, 2022

Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, rela...

Jan 20, 2022

Suneva Medical Inc. inked a merger agreement with Viveon Health On January 12, 2022, Suneva Medical Inc., a leading regenerative aesthetics company, and Viveon Health Acquisition Corp., a particular purpose acquisition company, entered into a definitive merger agreement to establish a new regenerative aesthetics...

Jan 18, 2022

Algernon receives positive FDA feedback on Phase IIb chronic cough trial The US Food and Drug Administration (FDA) has given positive feedback for Algernon Pharmaceuticals’ Phase IIb clinical trial of NP-120 (ifenprodil) for chronic cough treatment.  A receptor antagonist of N-methyl-D-aspartate (NMDA), ifenp...

Jan 11, 2022

Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...

Jan 06, 2022

Siemens Healthineers received Emergency Use Authorization for CLINITEST® Rapid COVID-19 Antigen Self-Test by the FDA  On December 29, 2021, Siemens Healthineers was granted Emergency Use Authorization (EUA) for its CLINITEST Rapid COVID-19 Antigen Self-Test by the United States Food and Drug Administration ...

Jan 04, 2022

FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...

Dec 30, 2021

Oracle Corporation sets to acquire Cerner Corporation  On December 20, 2021, Oracle Corporation and Cerner Corporation entered into an agreement as per which Oracle will acquire Cerner through an all-cash tender offer for approximately USD 28.3 billion in equity value.  Larry Ellison, Chairman and C...

Dec 28, 2021

Biogen-Eisai's potential Aduhelm sequel drug secured speedy review by FDA Biogen and Eisai’s Alzheimer’s disease treatment-in-waiting, lecanemab, has been secured a fast-track tag by the FDA, setting up a potentially swift path through the regulatory process. The drug is the next in line behind the pair’s app...

Dec 23, 2021

Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia  On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory bl...

Dec 16, 2021

First patient enrolled in BrainQ's Pivotal Trial, EMAGINE™, for frequency-tuned electromagnetic field therapy to reduce disability following Ischemic Stroke   On December 09, 2021, BrainQ announced the enrollment of the first patient at MedStar National Rehabilitation Hospital in its pivotal, randomized, ...