Infertility, historically regarded as a personal challenge and costly medical issue, is now prominently featured on the global public-health agenda
Glenmark Pharmaceuticals has gained clear momentum in its U.S. pipeline after the USFDA completed a pre?approval inspection of its formulations plant in Chhatrapati Sambhajinagar. The inspection revealed zero 483 observations that reflects...
Piramal Pharma Solutions announced today that it has completed its journey to global nitrosamine compliance, marking a major step in strengthening patient safety and meeting evolving international expectations for nitrosamine impurities in...
The Sun Pharmaceutical Industries has secured approval from the U.S. Food and Drug Administration (FDA) for an expanded label for its immunotherapy drug UNLOXCYT (cosibelimab ipdl). The updated label authorizes UNLOXCYT for use in adults with...
AstraZeneca’s Imfinzi has received US approval today for use with FLOT chemotherapy in adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The regimen includes Imfinzi before surgery...
Abbott has announced a medical device correction for select FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S., after internal testing revealed that some units may deliver incorrect low glucose readings.The company says this flaw...
Dr. Shashank Teotia, CHRO, Paras Health, is a strategic human capital leader with over 22 years of experience across healthcare, edtech, ecommerce, insurance, FMCG and retail. He specialises in organisation design, culture building and leadership
Shilpa Medicare, Eight Observations, Unit IV, Jadcherla Telangana, Ten-Day Inspection, Sterile Injectables, Oral Tablets, Capsule Production, Regulatory Approvals, US Sales, Key Agencies, Consolidated Profit
The Central Drugs Standard Control Organisation (CDSCO) has informed procurement agencies, including hospitals, that a license from Indian licensing authorities must be obligatory for acquiring devices, with additional certifications required beyond
Roche has received conditional marketing approval in Europe for Lunsumio, a new subcutaneous form of its bispecific antibody that can be administered in a quick, one?minute injection. This approval marks one of the significant changes in the...