Senores Pharmaceuticals acquires ANDA for Roflumilast 250 mcg and 500 mcg tablets

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated

Lupin receives EIR from USFDA for its Somerset manufacturing facility

the inspection conducted from January 27 to January 31, 2025

Merck’s Welireg receives European approval for two indications

WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union

GSK’s Penmenvy approved by FDA to help protect against MenABCWY

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)

Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru

Merck reports 2024 sales at $64.2 billion

The company anticipates 2025 worldwide sales to be between $64.1 billion and $65.6 billion

Philogen completes patient enrollment of Phase III FIBROSARC trial in Soft Tissue Sarcoma

These results represent critical milestones for Philogen, as Fibromun has the potential to become second product to successfully complete multinational clinical trials with registration potential

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025