FDA Archives - Page 159 of 220

3 minute read

Lixte Biotechnology Announces Approval Of A Phase 1B/2 Randomized Trial Of Doxorubicin +/-lb-100 In Advanced Soft Tissue Sarcomas To Be Conducted By The Spanish Sarcoma Group

October 13, 8:42 AM

LIXTE Biotechnology Holdings, Inc. (NASDAQ:LIXT), ("LIXTE" or the "Company"), a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, announced that

LIXT

1 minute read

FDA Signals Shortage For Teva Pharma’s ADHD Drug Due To Manufacturing Delay

By Vandana Singh

October 13, 6:25 AM

The FDA said that there was a shortage of Adderall after intermittent manufacturing delays at Teva Pharmaceutical Industries Ltd (NYSE: TEVA).

TEVA

2 minute read

Reported Early Thursday, ObsEva Announces IND Approval For Yuyuan Bioscience’s Phase 1 Clinical Trial Of Nolasiban To Improve Clinical Pregnancy And Live Birth Rates In Women Undergoing In Vitro Fertilization In China

By Benzinga Newsdesk

October 13, 1:22 AM

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange GENEVA, Switzerland – October 13, 2022 – ObsEva SA (NASDAQ:OBSV, SIX: OBSN)))), a biopharmaceutical company developing novel

OBSV

3 minute read

Nevro Late Wednesday Announces FDA Approval Of HFX iQ Spinal Cord Stimulation System To Personalize The Treatment of Chronic Pain

By Benzinga Newsdesk

October 13, 1:08 AM

Next Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient's Response REDWOOD CITY, Calif., Oct. 12,

NVRO

1 minute read

Why Evofem Biosciences Shares Are Plunging Today?

By Vandana Singh

October 12, 2:17 PM

Evofem Biosciences Inc's (OTC: EVFM) recently completed the Phase 3 EVOGUARD trial evaluating Phexxi vaginal gel (EVO100) to prevent chlamydia and gonorrhea infection in women but did not achieve its endpoints.

EVFM

2 minute read

Cassava Sciences Has Initiated And Started Enrollment For A New Open Label Extension To Their Phase 3 Trial Of Simufilam For The Treatment Of Alzheimer’s Disease

By Benzinga Newsdesk

October 12, 11:31 AM

Open-label Extension for Phase 3 Clinical Trials of Simufilam - Full Text View - ClinicalTrials.gov Brief Summary: The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam

SAVA

2 minute read

COMPASS Pathways Announces Phase 3 Pivotal Program Design For COMP360 Psilocybin In Treatment Resistant Depression At Capital Markets Day

By Benzinga Newsdesk

October 12, 11:10 AM

COMPASS Pathways plc (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the Phase 3 pivotal program design for COMP360

CMPS

2 minute read

Moderna Receives FDA Authorization For Emergency Use Of Omicron-Targeting Bivalent COVID-19 Booster Vaccine For Children And Adolescents 6 To 17 Years Of Age

By Benzinga Newsdesk

October 12, 10:43 AM

mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron Variant Authorization Is Based Upon Clinical and Pre-Clinical Data for Moderna's Bivalent Vaccine Candidates CAMBRIDGE, MA / ACCESSWIRE / October 12, 2022

MRNA