Granules receives USFDA nod for Potassium Chloride Extended-Release Tablets USP Medical Dialogues Bureau7 March 2020 10:00 AM ISTPotassium Chloride ER Tablets are used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom...
USFDA accepts regulatory submission for tanezumab for management of chronic pain due to osteoarthritis Medical Dialogues Bureau7 March 2020 10:00 AM ISTTanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF)...
Alembic Pharma bags USFDA nod for doxycycline hyclate tablets MD bureau6 March 2020 9:15 AM ISTDoxycycline hyclate tablets 20 mg have an estimated market size of USD 7 million for the 12-month period ending December 2019
Valisure Detects High Levels of NDMA in Metformin Medical Dialogues Bureau5 March 2020 9:00 AM ISTFDA currently recognizes the danger of this compound and, as a result, has set strict daily acceptable intake limits and advised companies to recall...
Sanofi gets USFDA nod for Sarclisa (isatuximab-irfc) for refractory multiple myeloma Medical Dialogues Bureau4 March 2020 12:11 PM ISTSarclisa offers an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two...
Strides get USFDA nod for Tetracycline Hydrochloride Capsules Medical Dialogues Bureau4 March 2020 9:30 AM ISTTetracycline Hydrochloride Capsule is an antibiotic used to treat many different bacterial infections of the skin, intestines, respiratory tract,...
Novartis updates on uses and safety of Beovu in patients with wet AMD Medical Dialogues Bureau3 March 2020 10:00 AM ISTIf clinical signs of intraocular inflammation or changes in vision after Beovu injection are observed doctor should perform the appropriate diagnostic...
COVID-19: USFDA updates about supply chain effect on medicines, devices and PPE Medical Dialogues Bureau1 March 2020 2:45 PM ISTA manufacturer has alerted that a shortage of a human drug that was recently added to the drug shortages list.
FDA Advisory approves Lilly's CYRAMZA (ramucirumab) for type of lung Cancer Medical Dialogues Bureau1 March 2020 2:00 PM ISTThe ODAC considered the safety and efficacy data from the Phase 3 RELAY trial, which is the basis for the CYRAMZA supplemental Biologics License...
Biohaven Receives Fda Approval for acute migraine drug Medical Dialogues Bureau1 March 2020 12:30 PM ISTA single quick-dissolving tablet of NURTEC ODT can provide fast pain relief and return patients to normal function within one hour, and deliver...
Dr Reddy's Laboratories launches generic of Naproxen, Esomeprazole Magnesium Delayed-Release Tablets Medical Dialogues Bureau29 Feb 2020 1:30 PM ISTDr Reddy's Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of...
Biocon Small Molecules API Manufacturing Facility Completes Post -Approval and GMP USFDA Inspection Medical Dialogues Bureau29 Feb 2020 11:35 AM ISTNew Delhi: Drug API maker, Biocon has informed that the U.S. Food and Drug Administration (FDA) conducted a Post-Approval and GMP inspection of Small...