Bayer Seeks EMA Approval for Elinzanetant to treat vasomotor symptoms

The biotechnology firm Bayer has requested approval from the European Medicines Agency (EMA) for elinzanetant to treat moderate to severe vasomotor symptoms (VMS, commonly known as hot flashes) linked to menopause or triggered by adjuvant...

India Hikes Drug Prices by 50% to Ensure Availability of Key Medicines

India's drug pricing regulator has raised the maximum price of 11 scheduled formulations by 50% to guarantee their accessibility. The majority of these medications are commonly used as initial treatment options for a range of conditions such as...

Zealand Pharma Receives FDA CRL for Pediatric Dasiglucagon

Zealand Pharma A/S, a biotech company specializing in peptide-based drugs, revealed that the FDA has issued a Complete Response Letter (CRL) for Part 1 of the NDA for dasiglucagon for treating hypoglycemia in children with CHI. The CRL is...

FDA Approves Exact Science's Cologuard Plus Test After BLUE-C Study

Exact Sciences Corp., a top supplier of cancer screening and diagnostic exams, disclosed that the Cologuard Plus test, the firm's advanced multitarget stool DNA test, was given the approval by the US Food and Drug Administration (FDA)...

Enhancing Compliance through Effective Pharmaceutical Regulatory Affairs Strategies

Owing to the direct impact of its products on public health & safety, the pharma sector operates within a highly regulated environment

Venus Remedies Receives Market Authorisations for two cancer drugs

Venus Remedies Ltd, a leading pharmaceutical company, announced that it has obtained approvals to market two important oncology medications (carboplatin and bortezomib) in Morocco and the Philippines. "These approvals are pivotal in our...

Fostering a Quality Culture in the Pharmaceutical Industry

CDSCO, in partnership with IDMA and the Drugs Control Administration of Dadra & Nagar Haveli and Daman & Diu, held a "One Day Workshop on Quality Culture" during which Dr. S. Eswara Reddy, Joint Drugs Controller (India), CDSCO, shared his views on...

Antengene Bags Thailand FDA Approval To commercialize Xpovio

Antengene Corporation Limited, a top creative, internationally-operating biopharmaceutical company focused on finding, creating, and selling top-of-the-line medications for cancer, revealed that the Thailand Food and Drug Administration has given...

Cabinet Nods Health Coverage For Senior Citizens Aged 70 years & above

The Prime Minister Narendra Modi-led Union Cabinet has given the green light for health coverage for all elderly citizens aged 70 and above, regardless of income, as part of the main scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana...

EMA Nods pre-filled syringe For administration of Eylea 8 mg in EU

The pre-filled syringe for administering Eylea 8 mg (114.3 mg/ml solution for injection) has been authorized by the European Medicines Agency (EMA) for use in the European Union. The recently introduced pre-filled syringe OcuClick offers...

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