Fierce Pharma

MARCH 11, 2024

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

FDA 349

FDA Biopharma 349

European Pharmaceutical Review

MARCH 7, 2024

Lastly, there is growing prominence and interest in radioligand therapeutics within major pharmaceutical companies, who are increasingly investing in this field, evident through recent acquisitions of Point Biopharma and RayzeBio. What makes targeted alpha therapies a promising new approach against cancer?

Manufacturing 52

Manufacturing Food and Drug Administration Marketing Management 52

MedCity News

MARCH 14, 2024

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence.

FDA 126

FDA Pharma Pharmaceutical Biopharma 126

MedCity News

MARCH 6, 2024

This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.

Patients 114

Patients FDA Pharmaceutical Biopharma 114

MedCity News

MARCH 26, 2024

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.

FDA 121

FDA Pharma Biopharma 121

MedCity News

MARCH 31, 2024

The FDA rejected the drug two years ago due to concerns about cardiovascular safety. Approval of Akebia Therapeutics’ Vafseo is based on additional post-marketing safety data from Japan, where the drug has been used since 2020.

FDA 106

FDA Safety Marketing Biopharma 106

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

Side effects 105

Side effects FDA Patients Biopharma 105