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Results For "Food-and-Drug-Administration"

1262 News Found

OneSource receives EIR with VAI classification from USFDA for BLD facility
Drug Approval | January 29, 2025

OneSource receives EIR with VAI classification from USFDA for BLD facility

OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer
Drug Approval | January 18, 2025

Datroway approved in the US for patients with previously treated metastatic HR-positive breast cancer

Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations


Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
News | January 16, 2025

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
Drug Approval | January 09, 2025

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024