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CDSCO APPROVAL
The hidden cost of looking better: What health insurance covers, and what it leaves you to payRising demand for weight-loss drugs, cosmetic procedures and wellness treatments is creating a growing out-of-pocket healthcare expense cat...- AstraZeneca's Enhertu gets regulatory approval in India for first-line HER2-positive breast cancerAstraZeneca Pharma India has secured approval from India's drug regulator for its smart chemotherapy drug Enhertu. This allows for its impo...
- Zydus Semaglutide approval: Delhi HC directs CDSCO to decide on patient safety concernsThe Delhi High Court has asked the Central Drugs Standard Control Organisation to review a petition challenging Zydus Lifesciences' approva...
- Wockhardt secures US FDA approval for antibiotic ZaynichWockhardt's novel antibiotic, Zaynich (cefepime and zidebactam), has received US FDA approval for complicated urinary tract infections. Thi...
- Wockhardt shares jump 8%, extend rally after CDSCO nod for Zaynich antibioticWockhardt shares surged after the company received CDSCO approval for its breakthrough antibiotic Zaynich in India. Strong Phase 3 trial re...
- Zydus Therapeutics' saroglitazar drug granted priority review by US FDAZydus Therapeutics' drug saroglitazar has received priority review from the US FDA. This drug treats primary biliary cholangitis, a liver d...
- Wockhardt gets CDSCO nod for Zaynich antibioticWockhardt Ltd has secured approval from the CDSCO for its new antibiotic, Zaynich. This drug is developed in India and will be used to trea...
- No cosmetic job with jabs, warns drug regulator CDSCOThe notice issued by the Central Drugs Standard Control Organisation (CDSCO) cites provisions of the Drugs and Cosmetics Act, 1940, and the...
- Dr Reddy’s launches oral semaglutide in IndiaDr Reddys Laboratories has launched its oral semaglutide biosimilar for type 2 diabetes in India. The drug, Obeda, is available in three ta...
- Indian pharma firms flood west Africa with powerful opioids despite crackdown: AFP investigationIndian pharmaceutical firms are exporting millions of dollars worth of powerful tapentadol opioids to West Africa, fueling a deadly drugs e...
- Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...
- Drug regulator cracks down on delayed safety reporting by pharma companiesIndia's drug regulator CDSCO has issued new rules for drug safety reporting. Companies must now submit safety reports from the actual launc...
- Overhaul of drug regulator begins with recruitment plan for 1,500 specialistsIndia's pharmaceutical landscape is on the verge of transformation! The country’s drug regulatory body is gearing up for an overhaul with t...
- Drug applications with unanswered queries to be rejected within 30 daysThe message was conveyed through a public notice issued by The Central Drugs Standard Control Organisation (CDSCO) on May 4. It said applic...
- Dr Reddy's gets nod to roll out generic oral semaglutide drug"The formulation was clinically evaluated in a head-to-head comparative study conducted in India, which established the non-inferiority to ...
- Centre to soon set up a digital portal to track narcotic drugsThe proposed platform will enable real-time, end-to-end digital tracking of all regulated pharmaceutical products, covering every stage fro...
- Govt orders safety review of popular weight-loss drugs amid rising demandIndian authorities are increasing vigilance on popular weight loss drugs. Indian Pharmacopoeia Commission will now compile reports on adver...
- Are your eye drops safe? CDSCO flags illegal products, doctors issue strong warning on irritation, conjunctivitisAuthorities have launched a major crackdown on unapproved dry eye relief drops being sold without mandatory CDSCO approval. States and Unio...
- AstraZeneca Pharma India gets CDSCO approval to import, sell cancer treatment medicineAstraZeneca Pharma India has received approval from CDSCO to import and distribute the cancer treatment drug Durvalumab solutions. This app...
- CDSCO waives local trials for drugs approved in major marketsThe Central Drugs Standard Control Organisation (CDSCO) has decided to waive local clinical trials for certain drugs approved in select ICH...
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