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DCGI APPROVAL
Alkem Labs shares in focus as Goldman, Morgan Stanley, others purchase stake in Rs 930-crore block dealShares of Alkem Laboratories will be in focus after block deals worth around Rs 930 crore saw 17.88 lakh shares traded at Rs 5,200 apiece o...- Alkem rolls out single-shot semaglutide syringes at Rs 350 for diabetes, weight lossAlkem Laboratories has launched semaglutide in single-shot pre-filled syringes in India. This makes treatment more accessible and affordabl...
- Wockhardt shares rocket 19% after FDA approval for antibiotic targeting drug-resistant infections. Check detailsWockhardt's shares surged 19% after the U.S. FDA approved ZAYNICH, a novel intravenous antibiotic for complicated urinary tract infections....
- Roche brings 7-minute lung cancer shot to IndiaRoche Pharma India introduces a new injectable immunotherapy for lung cancer. This treatment takes only seven minutes, a significant reduct...
- Roche Pharma launches India’s first 7-minute injectable immunotherapy for lung cancerRoche Pharma has introduced Tecentriq, India's first under-the-skin immunotherapy for lung cancer. This new injection takes about seven min...
- 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 halves approval timelines, eases several rulesIndia's drug regulator has significantly accelerated innovation by cutting approval timelines by over 50%. Clinical trial approvals now tak...
- Dr. Reddy’s Lab launches India’s first DCGI-approved Semaglutide injection for Type 2 DiabetesDr. Reddy's Laboratories has launched Obeda, a generic semaglutide injection for Type 2 diabetes, becoming the first Indian company to rece...
- 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.
- 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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