FDA Approval, Marketing and Nurses - Drug Discovery Digest

Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Drug Target Review

JUNE 5, 2025

Dr Aaron Haubner, Senior Manager of North America Medical Affairs and Market Access at Terumo Blood and Cell Technologies , reveals that while promising new treatments emerge, urgent partnerships are needed to ensure this essential blood therapy reaches the patients who need it most. JAMA Netw Open. 2023 Nov 1;6(11):e2344546. 2023.44546.

Disease

Disease Treatment Therapies Nurses

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

FDA Approval

FDA Approval Treatment FDA Clinical Trials

Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

The Pharma Data

NOVEMBER 10, 2020

The paper goes on to state, “The results from the nurse questionnaire, as well as the successful deployment of the SAMI in our institution during the pandemic with only 3-hour virtual training support that operating the SAMI is simple and safe. DIMI” recently received its FDA 510k clearance for use in hospital and clinical settings.

Therapies

Therapies Nurses FDA FDA Approval

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Hospitals

Hospitals Production Clinical Trials Virus

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

JANUARY 12, 2021

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Government

Government Hospitals Virus Clinical Trials

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. REGN-COV2 (casirivimab and imdevimab) FDA Approval History. About Regeneron. Source link.

Therapies

Therapies FDA Clinical Trials Hospitals

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

FDA

FDA Clinical Trials Hospitals Production

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals

Hospitals Trials Clinical Trials Production

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.”

FDA

FDA Regulations Production Packaging

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. It is not known whether OPDIVO or YERVOY is present in human milk.

Therapies

Therapies Trials Disease Treatment

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. It is not known whether OPDIVO or YERVOY is present in human milk.

Treatment

Treatment Trials Therapies Clinical Trials

Trospium chloride

New Drug Approvals

APRIL 27, 2025

3] It was patented in 1966 and approved for medical use in 1974. [6] 6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. 3] The drug was studied in children. [3]

FDA Approval

FDA Approval FDA Pharmacokinetics Licensing

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. In Michigan, the longstanding presumption of non-defectiveness enjoyed by FDA-approved products was repealed. Preemption.

Testimonials

Testimonials Drugs FDA Vaccine

A Painful Preemption Decision

Drug & Device Law

JANUARY 9, 2023

2022 WL 17348351, at *4. “[F]or certain categories of drugs” – including this one – “the monograph system replaces the individualized NDA approval process with a rulemaking process.” The FDA also promulgated an acetaminophen-specific OTC regulation. Plaintiffs Legal Committee , 531 U.S. 2022 WL 17348351, at *4. 201.326(a)(1).

Regulations

Regulations FDA Nurses FDA Approval

Drug Discovery Digest

Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults

Trending Sources

Spectral Medical Announces Report on Clinical Implementation of SAMI Amid COVID-19 Published in the Journal of Blood Purification

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

Trospium chloride

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

A Painful Preemption Decision

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