Pharma's Almanac

485 Articles Available

1 21

Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

mRNA–LNP Manufacturing

The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles

PAO-03-24-CL-08

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

PAO-09-23-CL-07

Continuous Processing

US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.

PR-M07-23-03

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

PAO-05-23-CL-02

Cosmeceuticals

Cosmeceuticals Are Here. When Will Regulations Catch Up?

PAO-08-022-CL-09

Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

PAO-06-022--NI-05

Alzheimer's Diagnostic Test

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease

PR-M05-22-02

COVID-19 Breathalyzer Diagnostic

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

PR-M04-22-09

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

PAO-03-022-NI-03

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

PR-M03-22-03

Drug Update

AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S.

PR-M07-21-011

FDA Approval

FDA Grants Accelerated Approval for Aduhelm™ as the First and Only Alzheimer’s Disease Treatment to Address a Defining Pathology of the Disease

PR-M06-21-015

FDA Approval

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

PR-M06-21-008

FDA Approval

Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis

PR-M06-21-002

COVID-19 Diagnostic

FDA Authorizes First Single-Use, PCR Quality Over the Counter (OTC) LUCIRA CHECK IT™ COVID-19 At-Home Test. Available Now.

PR-M04-21-016

AI

Cosmo Announces Fda Approval of Gi Genius™ Intelligent Endoscopy Module, Its Revolutionary Artificial Intelligence Device for Lesion Detection During Colonoscopy

PR-M04-21-015

FDA Approval

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

PR-M04-21-007

FDA Approval

United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

PR-M04-21-003

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

PR-M11-20-028

FDA Authorization

Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19

PR-M11-20-022

Fast Track

Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer

PR-M11-20-012

Decentralized Trials

Protecting Clinical Research and Patients Through Decentralized Trial Strategies

PAP-Q3-20-CL-025

Oral COVID-19 Vaccine

Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine

PR-M09-20-NI-19

1 21

FDA

485 Articles Available

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Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

mRNA–LNP Manufacturing

The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

Continuous Processing

US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

Cosmeceuticals

Cosmeceuticals Are Here. When Will Regulations Catch Up?

Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

Alzheimer's Diagnostic Test

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease

COVID-19 Breathalyzer Diagnostic

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Drug Update

AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S.

FDA Approval

FDA Grants Accelerated Approval for Aduhelm™ as the First and Only Alzheimer’s Disease Treatment to Address a Defining Pathology of the Disease

FDA Approval

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

FDA Approval

Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis

COVID-19 Diagnostic

FDA Authorizes First Single-Use, PCR Quality Over the Counter (OTC) LUCIRA CHECK IT™ COVID-19 At-Home Test. Available Now.

AI

Cosmo Announces Fda Approval of Gi Genius™ Intelligent Endoscopy Module, Its Revolutionary Artificial Intelligence Device for Lesion Detection During Colonoscopy

FDA Approval

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

FDA Approval

United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

FDA Authorization

Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19

Fast Track

Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer

Decentralized Trials

Protecting Clinical Research and Patients Through Decentralized Trial Strategies

Oral COVID-19 Vaccine

Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine