Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time

Dr. Reddy's invests US$ 620 million in Switzerland subsidiary

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression

Baxter launches nextgen airway clearance system

Developed in consultation with clinicians and patients for an enhanced user experience

India reaffirms commitment to social determinants of health at UNGA

India called for stronger investments in health and social equity at G20 Joint Finance-Health Task Force Meeting

Torrent Pharmaceuticals refutes claims of Shelcal 500 allegedly failing CDSCO quality test

The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious

Takara Bio Europe unveils new large-scale NGS profiling system and chemistries

The Shasta system and Shasta Whole-Genome Amplification (WGA) Kit dramatically increase throughput for WGA by processing up to 1,500 cells per run

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity