FDA - Spark Newswire

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FDA
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Eagle Pharmaceuticals Submits Response to Complete Response Letter from FDA for Vasopressin

Today, 11:30 AM

Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) (“Eagle” or the “Company”) today announced that it has responded to the Complete Response Letter (“CRL”) for its Abbreviated New Drug

EGRX

1 minute read

Midatech Pharma Stock Jumps After Breakthrough Data On Encapsulation Of Biologic Using Q-Sphera

By Vandana Singh

Today, 11:30 AM

Midatech Pharma PLC (NASDAQ: MTP) has announced a breakthrough in vitro data utilizing Q-Sphera technology and progress across multiple other programs. The technology showed potential to formulate proteins into long-acting injectable products.

MTP

1 minute read

Satsuma Stock Is Trading Higher As STS101 Shows Favorable Pharmacokinetic Profile, Tolerability In Early-Stage Study

By Vandana Singh

Today, 11:30 AM

Satsuma Pharmaceuticals Inc (NASDAQ:STSA) announced positive Pharmacokinetic and safety results from a Phase 1 trial of STS101 (dihydroergotamine (DHE) nasal powder).…

STSA

2 minute read

FDA
News

Pfizer Highlights Data Published In New England Journal Of Medicine Shows Co’s Tofacitinib Meets Primary Endpoint In Brazilian Study In Patients Hospitalized With COVID-19 Pneumonia

By Benzinga Newsdesk

Today, 11:30 AM

Pfizer Inc. (NYSE:PFE) and The Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein today announced that the New England Journal of Medicine has published positive findings from the

PFE

6 minute read

FDA
News

CureVac Issues PR Confirming Earlier News Co’s COVID-19 Vaccine Demonstrated An Interim Vaccine Efficacy Of 47% Against COVID-19 Disease Of Any Severity And Did Not Meet Prespecified Statistical Success Criteria

By Benzinga Newsdesk

Today, 11:30 AM

Pivotal study conducted in 10 countries in fast changing environment of at least 29 COVID-19 variant strains; original strain almost completely absent At second interim analysis, statistical success criteria not met.

CVAC

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FDA
News

CureVac Says COVID-19 Vaccine Demonstrated An Interim Vaccine Efficacy Of 47% Against COVID-19 Disease Of Any Severity And Did Not Meet Prespecified Statistical Success Criteria

By Benzinga Newsdesk

Today, 11:30 AM

https://www.curevac.com/en/2021/06/16/curevac-provides-update-on-phase-2b-3-trial-of-first-generation-covid-19-vaccine-candidate-cvncov/

CVAC

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FDA
News

CureVac Provides Update On Phase 2b/3 Trial Of First-Generation COVID-19 Vaccine Candidate, CVnCoV

By Benzinga Newsdesk

Today, 11:30 AM

https://www.curevac.com/en/2021/06/16/curevac-provides-update-on-phase-2b-3-trial-of-first-generation-covid-19-vaccine-candidate-cvncov/

CVAC

2 minute read

Biogen Announces Topline Results From Phase 2 Study Of Gosuranemab; Says Did Not Meet Primary Efficacy Endpoint Of Change From Baseline At Week 78

By Benzinga Newsdesk

Today, 11:30 AM

Biogen Inc. (NASDAQ:BIIB) today announced topline results from its Phase 2 TANGO study of gosuranemab (BIIB092), an investigational anti-tau antibody that was being evaluated as a potential treatment for

BIIB

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FDA
News

Collegium Pharma Highlights Publication Of ‘Nonmedical Use of Xtampza® ER and Other Oxycodone Medications in Adults Evaluated for Substance Abuse Treatment’ In Journal Of Pain Research

By Benzinga Newsdesk

Today, 11:30 AM

Collegium Pharmaceutical, Inc. (NASDAQ:COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today announced a publication titled, “Nonmedical Use of

COLL