FDA Approval, Hospitals and Nurses - Drug Discovery Digest

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

Drug Target Review

JUNE 5, 2025

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. 3,20 These crises drive high rates of emergency department use and hospital admissions, significantly disrupting education, employment and family life.

Disease

Disease Treatment Therapies Nurses

DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

FDA Approval

FDA Approval FDA Clinical Trials Trials

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

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals

Hospitals Production Clinical Trials Virus

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 FDA Nurses FDA Approval

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI. BioXcel Therapeutics, Inc.

Treatment

Treatment Trials FDA Hospitals

FDA Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 12, 2020

Health care workers and nursing home residents and staff should get the initial shots, according to guidelines issued recently by a U.S. The nursing home industry applauded the approval. The association represents 14,000 nursing homes and assisted living facilities. ” Who is first in line to be vaccinated?

Vaccine

Vaccine FDA Approval FDA Nurses

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

JULY 2, 2025

This trial was the first in its therapeutic area to use a composite primary endpoint consisting solely of major morbidity and mortality events , such as all-cause death, lung transplantation, or PAH-related hospitalization of at least 24 hours. WINREVAIR is the first FDA-approved activin signaling inhibitor for PAH.

Trials

Trials FDA Licensing Licensing

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

The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D., In the U.S.

Government

Government Hospitals Virus Clinical Trials

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

The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

Hospitals

Hospitals Trials Clinical Trials Production

DermaPrime

The Pharma Data

MAY 16, 2021

Description: I’ve been a researcher for over 15 years at one of the biggest hospitals in Cleveland, Ohio. Every capsule is made here, in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. DermaPrime Plus capsules are non-GMO and safe.

Production

Production Nurses FDA Approval Packaging

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 are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

Therapies

Therapies FDA Clinical Trials Hospitals

FDA Set to Approve Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 11, 2020

Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. Third of Americans live where hospitals are short on ICU beds.

Vaccine

Vaccine FDA Hospitals Doctors

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 are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D.,

FDA

FDA Clinical Trials Hospitals 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. Six of the 9 patients were hospitalized for severe endocrinopathies.

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. Six of the 9 patients were hospitalized for severe endocrinopathies.

Treatment

Treatment Trials Therapies Clinical Trials

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

Hospitals

Hospitals Treatment Trials Long-Term Care Facilities

Here We Go Again – Monkeypox Communications Challenges

Eye on FDA

AUGUST 8, 2022

The only FDA-approved drug to treat is approved for smallpox, but no Monkeypox and has been difficult to access. But people may have other symptoms such as headache, chills, muscle aches, swollen lymph nodes and exhaustion. What to Do. Every business, service or place of public accommodation is different.

Virus

Virus Vaccine Nurses Hospitals

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. call your healthcare provider or go to the nearest hospital emergency room right away. at your regular time on the next day.

Treatment

Treatment Therapies FDA FDA Approval

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. call your healthcare provider or go to the nearest hospital emergency room right away. at your regular time on the next day.

Treatment

Treatment FDA Therapies FDA Approval

Design Defect Claim Dismissed in W.D.N.Y. Fosamax Case

Drug & Device Law

MAY 13, 2022

And we are out of the hospital (first the step-down ICU then a regular room) and six days into rehab. We offer this comment: those who choose to enter the nursing professions – RNs, LPNs, aides – deserve a special place in any afterlife your beliefs include. A painful injury with a long recovery time, but miraculous all in all.

Nurses

Nurses FDA Approval Production Drugs

Drug Discovery Digest

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

DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

Trending Sources

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

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

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

FDA Approves Emergency Use of Pfizer’s COVID Vaccine

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

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

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

DermaPrime

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

FDA Set to Approve Pfizer’s COVID Vaccine

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

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

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Here We Go Again – Monkeypox Communications Challenges

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study

CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

Design Defect Claim Dismissed in W.D.N.Y. Fosamax Case

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