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- Read more about Gilead submit US FDA approval for Fixed-Dose Combination of emtricitabine/tenofovir alafenamide for HIV treatment
Gilead Sciences has submitted a new drug application (NDA) to the FDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients aged 12 years and older, in combination with other HIV antiretroviral agents.
- Read more about Novo Nordisk opens modern insulin formulation and filling facility in Russia
Novo Nordisk opens a new manufacturing facility in Russia for formulation and filling of modern insulin for the treatment of diabetes. The production will cover both Penfill® cartridges and FlexPen® prefilled insulin injection pens for the Russian market.
- Read more about Oncolytics REOLYSIN seeks US FDA orphan drug status to treat gastric cancer
Oncolytics Biotech Inc., a biotechnology company concentrated on the development of oncolytic viruses as potential cancer therapeutics. Company has presented an application to the US Food and Drug Administration (FDA) for REOLYSIN to get Orphan Drug Designation for the treatment of gastric cancer.
- Read more about Health ministry to amend Form 12-B of D&C Rules
Health ministry to amend Form 12-B of D&C Rules; Form 12-B of the Drugs and Cosmetics Rules is for giving permission for import of small quantities of drugs for personal use. The Union health ministry will soon amend Rules in this regard.

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- Read more about FDA ordered strict warning for anemia drug Feraheme
The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug “Feraheme”. It could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product. Health care professionals should strictly follow the recommendations mentioned in the drug label. Patients should immediately call doctor if there is breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
- Read more about FDA approves breath test for treatment of gastroparesis
The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.
- Read more about Biocon Strengthens its Presence in Mexico, Receives Approval for Insulin Glargine through its Partner PiSA Farmaceutica
Biocon Ltd, Asia's premier biopharmaceuticals company, announced that its Insulin Glargine has been approved by COFEPRIS, the Mexican health authority, through its partner PiSA Farmaceutica (PiSA).
- Read more about Glenmark receives US FDA approval for norethindrone acetate and ethinyl estradiol tablets USP
Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics, has received the final approval from the United States Food and Drug Administration (USFDA) for sale of drugs meant to prevent post-menopause osteoporosis.USFDA granted Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg.
- Read more about Live monitoring of fetal heart rate, First time in india
The cumbersome days of stressful, manual, wired monitoring of the unborn child in pregnant mothers will soon end - thanks to a new system unveiled at a hospital here. The Lokmanya Tilak Municipal General Hospital, known as the Sion Hospital, has introduced system in order to monitor the fetal heart rate and condition of the baby in the uterus of a pregnant lady for the first time in India.
- Read more about Ebola Vaccine shows Promise in Phase 1 Human Trial
Results from the phase 1 clinical trial of an Ebola vaccine based on the current strain of the virus suggests it is safe to use and provokes an immune response in recipients, Chinese scientists say. Until now, all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976.