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DCGI APPROVAL
Dr Reddy's gets DCGI nod for Zytorvi in advanced esophageal cancerDr Reddy's Laboratories has received approval for Zytorvi, an immunotherapy targeting advanced esophageal squamous cell carcinoma. This new...- National Formulary of India lists drugs not approved by CDSCO, DCGI seeks explanation from IPCThe National Formulary of India released its latest edition amidst concerns regarding unapproved drugs included in it. The Drug Controller ...
- Lupin launches fixed-dose triple combination inhaler for COPD in IndiaLupin Ltd has launched Formoflo-G MDI, a new inhaler for chronic obstructive pulmonary disease management in India. This fixed-dose inhaler...
- QDENGA dengue vaccine to hit India market in 2027; Dr Reddy’s to sell itIndia's first approved dengue vaccine, QDENGA, will launch in the private market by mid-2027. Dr Reddy's Laboratories will distribute and p...
- Dr. Reddy's launches nivolumab biosimilar in IndiaDr Reddy's Laboratories has taken a significant step in cancer care with the introduction of NIVORZ, a biosimilar of nivolumab. Designed to...
- Zydus’ Saroglitazar meets primary goal in global Phase II(b) MASH trialZydus Lifesciences said its drug Saroglitazar Magnesium met the primary goal of a global Phase II(b) trial for MASH, a serious liver diseas...
- Govt plans new drugs law to overhaul pharma, medical device regulationThe government is set to replace the 1940 Drugs and Cosmetics Act with a new law covering drugs, medical devices and cosmetics. The draft b...
- Glenmark to launch DCGI-approved cancer drug in IndiaGlenmark Pharmaceuticals is set to introduce zanubrutinib, a cancer treatment drug, in India. This follows approval from the Drugs Controll...
- DCGI suspends nod to Entod's new eye drops over unapproved 'claims'India's drug regulator has suspended Entod Pharmaceuticals' permission to manufacture and sell PresVu Eye Drops. The company did not obtain...
- Akumentis Healthcare launches drug for treatment of epilepsy"We understand the immense physical and emotional toll that frequent seizures can have on patients and their families," Akumentis Executive...
- DCGI's EUA nod to SII's Covovax for 12-17 yrs age group; Poonawalla says younger age groups to follow shortlyIt is the fourth vaccine to receive the regulator's nod for use among those below 18 years.
- 'Covishield' ready to roll out in coming weeks, says Serum Institute's Adar PoonawallaThe Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
- Approval for vaccines accelerates India's journey to be COVID-free, says ModiIn a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin ...
- Glenmark Pharma shares jump nearly 9% on DCGI nod for clinical trials of Covid-19 tabletsThe company said it is the first firm in India to receive such an approval from the DCGI.
- DCGI to fast-track approval for Covid-19 drug, vaccineThe DCGI has offered seven measures for speeding up the process, from giving fast-track approval for repurposed drug to waiving animal stud...
- Delhi High Court asks government what was the urgency to ban over 300 FDC drugsWhat was the urgency for banning the manufacture and sale of over 300 FDC medicines and how can approval DCGI be disregarded completely, De...
- Pharmaceutical companies including Cipla deny charges of collusion with drug regulator in drug trialsSeveral drug manufacturers accused of colluding with the sector regulator and medical experts to allegedly violate approval norms have deni...
- Drug approvals fall on account of tardy & tedious process by NDACCos allege NDAC has not been sticking to its deadline of giving decision within six weeks & when the committees meet, the approval is outri...
- Drug Regulator office has gone defunct as a quasi regulatory body takes charge of crucial approvalsDrug companies say that due to this committee, the DCGI has become non accountable to issues of drug approvals.
- Pharma dept wants drug controller's office under its ambitThe newly-formed department of pharmaceuticals wants to take Drug Controller General of India (DCGI) under its control.
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