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...
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)...
Owing to the direct impact of its products on public health & safety, the pharma sector operates within a highly regulated environment
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...
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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 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...
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...
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...
The FDA has approved Strides Pharma Global, Singapore's generic theophylline extended-release tablets, 300 mg and 450 mg.The product is identical in bioavailability and therapeutic effects to the Reference Listed Drug (RLD), THEO-DUR, from...
BlueRock Therapeutics LP, a company developing cell therapy in clinical stage and a subsidiary of Bayer AG, announced the FDA's approval of its IND application for OpCT-001, a treatment for primary photoreceptor diseases. BlueRock Therapeutics LP...
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