UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data ...
FiercePharma1d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company seeking FDA approval for ketamine, today announced that ...
Cure Today4d
Breaking Down the FDA Labeling Update of Xeloda and 5-FU in Cancer Care
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...
Cure Today3d
An Expert Breaks Down What DPD Is and Labeling Updates From The FDA
Dr. Gabriel A. Brooks discusses the recent FDA product labeling update for Xeloda and 5-FU which aims to highlight risks associated with DPD deficiency.
manilatimes18h
Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC)
PHILADELPHIA, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is also pleased to announce that its phase 2 clinical study (SKNJCT-003) which is ...
JD Supra2d
FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim
On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food ...
FDA recalls more than 2 million cases of doughnuts
The FDA recalled 60 doughnut products, totaling more than 2 million cases, for potential listeria contamination. The ...
JD Supra1d
Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use ...
Alnylam: Waiting For Regulatory Updates In March
Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.
More than 2M doughnut products recalled nationwide over listeria risk: FDA
The Food and Drug Administration has classified a recall of 60 different doughnut products to its second-highest level, the agency announced earlier this week in an update to its website.
Trader Joe's Products Recalled: Full List of Items Impacted
The nationwide recall affected Trader Joe's products including the White Meat Chicken Salad, Harvest Salad With Grilled ...