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Zydus Cadila gets US FDA approval for Cisatracurium Besylate Injection expresspharma
September 03, 2020
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex) in the strength of 20 mg (base)/10 mL (2 mg/mL) multiple-dose vial.
US FDA releases guidance to detect and prevent nitrosamines in drugs expresspharma
September 03, 2020
The US Food and Drug Administration (US FDA) has published guidance ‘Control of Nitrosamine Impurities in Human Drugs’ for immediate implementation.
US FDA issues warning to Mylan for Telangana plant expresspharma
September 03, 2020
The US FDA has issued a warning to Mylan after the inspection of its plant in Pashamylaram, Telangana. The inspection was from February 24 to 28 this year after which the drug regulator had issued a Form 483.
Lupin launches Leflunomide Tablets USP expresspharma
September 03, 2020
These tablets are indicated for the treatment of adults with active rheumatoid arthritis.
Improving FDA's COVID-19 vaccine authorization and approval process worldpharmanews
September 02, 2020
On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19.
FDA expands emergency use authorisation for remdesivir to treat all COVID-19 patients europeanpharmaceuticalreview
September 02, 2020
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
FDA Approves Automated Insulin Delivery, Monitoring System for Young Pediatric Patients americanpharmaceuticalreview
September 02, 2020
The U.S. Food and Drug Administration (FDA) approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input ...
FDA Grants Priority Review of Melflufen for Triple-Class Refractory Multiple Myeloma americanpharmaceuticalreview
September 02, 2020
Oncopeptides has announced the US Food and Drug Administration (FDA) has granted priority review for Oncopeptides' New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for ...
FiercePharmaPolitics—FDA would consider COVID vaccines before phase 3 trials finish, commissioner says fiercepharma
September 01, 2020
Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
Only drug inspectors can probe, file FIRs for certain cognizable offences under D&C Act 1940: SC expresspharma
September 01, 2020
The Supreme Court recently ruled that drug inspectors can carry out an investigation and file a first information report (FIR) related to cognizable offences which is specified as under the chapter IV of the Drug and Cosmetics Act 1940.

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