Sanofi wins USFDA approval to sell dengue vaccine Dengvaxia in parts of US Farhat Nasim2 May 2019 10:00 AM ISTDengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots...
AstraZeneca ties up with Transgene to develop viral immunotherapies Garima2 May 2019 9:25 AM ISTAstraZeneca has been moving deeper into cancer therapy market through wide-ranging deals, including those for immunotherapy and targeted therapy.New...
Glenmark launches SGLT2 Inhibitor Remogliflozin under brand names Remo, Remozen Meghna A Singhania30 April 2019 10:16 AM ISTGlenmark will commercialize Remogliflozin in India under the brand names 'Remo' and 'Remozen'.Mumbai: In a major relief to diabetics, Glenmark...
CDSCO approves Zydus, SIFI pact to launch Intraocular Lenses in India Farhat Nasim30 April 2019 10:15 AM IST"SIFI's innovative IOLs (Intraocular lenses) have been approved by the Indian Central Drugs Standards Control Organisation(CDSCO) (Directorate General...
Cipla gets USFDA nod for Ambrisentan tablets to treat pulmonary arterial hypertension Farhat Nasim30 April 2019 10:00 AM ISTCipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis.New Delhi: Drug major...
GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus Medical Dialogues Bureau30 April 2019 9:15 AM ISTNew Delhi: GlaxoSmithKline (GSK) has won the US Food and Drug Administration's (USFDA) approval for its Benlysta (belimumab) intravenous (IV) infusion...
Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer Farhat Nasim29 April 2019 9:35 AM ISTThe positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
Roche withdraws refiling of Premerger Notification, Report Form under the HSR Act Farhat Nasim28 April 2019 9:45 AM ISTRoche has elected to withdraw and refile the Premerger Notification and Report Form under the HSR Act.New Delhi: Roche and Spark Therapeutics, Inc....
Sun Pharma gets 11 USFDA observations for Dadra plant, BSE asks for response: Report Farhat Nasim26 April 2019 2:20 PM ISTNew Delhi: Sun Pharmaceutical (Sun Pharma) Industries Ltd's Dadra plant has reportedly received 11 observations, "serious" in nature from the U.S....
Zydus Cadila gets final USFDA nod for Leflunomide tablets to treat arthritis Farhat Nasim26 April 2019 12:49 PM ISTLeflunomide tablet is used to treat rheumatoid arthritis, a condition affecting multiple small and large joints of the body.New Delhi: Drug firm Zydus...
Glenmark Pharma gets USFDA approval for generic version of VAGIFEM Farhat Nasim25 April 2019 10:50 AM ISTThe approved product Estradiol Vaginal Inserts USP, 10 mcg is a generic version of Novo Nordisk Inc's VAGIFEM. New Delhi: Glenmark Pharmaceuticals has...
Indoco Remedies: USFDA retains OAI status for Goa plant Farhat Nasim25 April 2019 9:50 AM ISTIndoco Remedies' spokesperson said that the move is likely to withhold approval of pending abbreviated new drug applications (ANDAs) from Goa...
