Alembic Pharmaceuticals Ltd announced that it has obtained approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules, which are used for treating hypertension. The company stated that the USFDA has...
GSK plc reported that the NDA for gepotidacin, a new oral antibiotic for treating female adults and adolescents with uUTIs, has been accepted by the US FDA. The FDA has decided to give Priority Review to this application and has set a PDUFA action...
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'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 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...
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