GSK's Nucala application for COPD accepted for review in China

Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally

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

Korea’s MFDS completes inspection at Concord Biotech's Dholka unit

The inspection was successfully completed

Lupin receives EIR from USFDA for its Somerset manufacturing facility

the inspection conducted from January 27 to January 31, 2025

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries

FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL

Approval is based on positive data from the Phase 3 ECHELON-3 trial

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

Cosmo and Glenmark receives UK MHRA approval to market Winlevi in UK

NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension

TFOS is indicated for the treatment of pulmonary arterial hypertension

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)

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

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older

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

Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide

Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis