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:...
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...
Patent Infringement: Cadila Healthcare, two others prohibited from launching Linagliptin Metformin Hydrochloride tablets Meghna A Singhania22 April 2019 2:07 PM ISTAHMEDABAD: In a major setback, three Gujarat based pharmaceutical companies including Cadila Healthcare, West Coast Pharmaceutical Works Ltd and Maan...
Alembic Pharma gets USFDA nod toTeriflunomide tablets, Tobramycin ophthalmic solution Farhat Nasim22 April 2019 11:55 AM ISTTeriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis while Tobramycin ophthalmic solution is a...
Merck wins USFDA approval for Keytruda as combo therapy for kidney cancer Farhat Nasim22 April 2019 9:30 AM ISTNew Delhi: Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (USFDA) has approved...
USFDA nod to Teva generic nasal spray-Narcan to treat opioid overdose Medical Dialogues Bureau21 April 2019 9:27 AM ISTThe U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a...
Zydus Cadila gets final USFDA nod to generic version of Diamox for injection Farhat Nasim18 April 2019 10:00 AM IST Acetazolamide injection is a generic version of Diamox for injection.New Delhi: Drug firm Zydus Cadila Wednesday said it has received the final nod...
Alembic Pharma receives USFDA nod for Bimatoprost Ophthalmic Solution Farhat Nasim15 April 2019 10:05 AM ISTBimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular...
