Newsfeeds Archive - Page 14 of 15

1 minute read

Avadel Secures FDA Tentative Approval For Excessive Daytime Sleepiness (EDS) Candidate

July 19, 7:59 AM

The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.

AVDL

3 minute read

Recap of Monday’s Biotech Catalysts – End of the Day Summary

By Ragothaman Srinivasan

July 18, 6:07 PM

Abbvie (NYSE: ABBV) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month.

ABBV

1 minute read

Acadia Seeks FDA Approval For Genetic Neurological Disorder Candidate

By Ragothaman Srinivasan

July 18, 4:53 PM

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome.

ACAD

1 minute read

NexImmune Shares Soar Following FDA’s Clearance To Initial-Stage HPV Cancer Study

By Ragothaman Srinivasan

July 14, 5:24 PM

NexImmune, Inc. (NASDAQ: NEXI) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for its first cellular therapy product candidate NEXI-003 addressing solid tumors.

NEXI

1 minute read

Omega Therapeutics Gets FDA Nod For Initial-Stage Liver Cancer Study

By Ragothaman Srinivasan

July 14, 4:55 PM

The U.S. Food and Drug Administration (FDA) has announced clearance to Omega Therapeutics’ (NASDAQ: OMGA) Investigational New Drug (IND) to initiate a Phase 1/2 clinical study of its candidate OTX-2002 for the treatment of hepatocellular carcinoma (HCC).

OMGA

1 minute read

U.S. FDA Defers Decision On BeiGene’s Filing For Esophageal Carcinoma Due To Pending Inspection

By Ragothaman Srinivasan

July 14, 10:33 AM

The U.S. Food and Drug Administration (FDA) has deferred decision on the Biologics License Application (BLA) for BeiGene’s (NASDAQ: BGNE) tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

BGNE

1 minute read

Lantern Pharma Gets FDA Clearance for Mid-Stage Lung Cancer Study

By Ragothaman Srinivasan

July 14, 9:31 AM

The Food and Drug Administration (FDA) has announced clearance to Lantern Pharma (NASDAQ: LTRN) to proceed with Phase 2 clinical trial of its investigational new drug LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (N

LTRN

1 minute read

Novavax Secures FDA Emergency Authorization For Adjuvanted Covid-19 Vaccine

By Ragothaman Srinivasan

July 13, 5:59 PM

The U.S. Food and Drug Administration (FDA) grants emergency use authorization (EUA) to Novavax’s (NASDAQ: NVAX) lead candidate Adjuvanted (NVX-CoV2373) COVID-19 Vaccine for individuals 18 years of age and over.

NVAX

1 minute read

ContraFect Shares Plummet After Data Safety Monitoring Board Stops Late-Stage Aureus Bacteremia Study

By Ragothaman Srinivasan

July 13, 4:42 PM

The Data Safety Monitoring Board (DSMB) has recommended that ContraFect’s (NASDAQ: CFRX) on going DISRUPT trial be stopped because the conditional power of the study was below the pre-specified threshold for futility.

CFRX