XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Production 98

XTalks

JULY 25, 2023

While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores. Overall, 66.3 on Day 64 in the study.

FDA Approval 98

FDA Approval Vaccine Vaccination Antibody 98

Camargo

AUGUST 5, 2021

Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. In July, Astellas Pharma US received FDA approval for the use of Prograf (tacrolimus) capsules, injection, and oral suspension for the prevention of lung transplant rejection.

Development 232

Development Production Regulation Clinical Trials 232

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. In its acquisitions, J&J also acquired antibody-drug conjugate (ADC) developer Ambryx and cardiac med tech Laminar along with more than 50 smaller, early-stage licensing deals and partnerships.

Pharma Companies 52

Pharma Companies Sales FDA Approval Vaccination 52

Pharmacy Checkers

DECEMBER 12, 2019

In fact, they have the exact same problems as we do in ensuring that the active pharmaceutical ingredients (APIs) used to make our drugs are of the highest quality and without contaminants. drug regulatory system, see: How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Why do I write “exact same”?

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Cloudbyz

AUGUST 19, 2024

Answer: Entering the global market requires compliance with various international regulations and standards, including: Regulatory Approval: Devices must meet the regulatory requirements of each country where they will be marketed, such as FDA approval in the U.S., CE marking in the EU, or TGA approval in Australia.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). If approved, TicoVac would be the first vaccine in the U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40