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US FDA grants breakthrough therapy status to Roche's Venclexta
Roche announced that Venclexta (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic
Chugai Pharma obtains regulatory approval for anti-SARS-CoV-2 monoclonal antibody Ronapreve
Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-SARS-CoV-2 monoclonal antibody Ronapreve for Intravenous Infusion Set 300 and Set 1332 for the indication of SARS-CoV-2 infection
US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness
The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg
Pack Expo Las Vegas to be held from 27th to 29th September, 2021
Pack Expo Las Vegas will be held from 27th to 29th September, 2021. The event will see the latest innovations, and solutions from experts at the packaging and processing event
In a bid to ramp up production of various drugs amid the looming threat of the third wave of Covid-19 pandemic, the Central government has extended the exemption of strict environmental clearance procedures for drug manufacturers till December 31, 2021
US FDA approves Merck's Vaxneuvance for prevention of invasive pneumococcal disease
Vaxneuvance is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of Vaxneuvance or to diphtheria toxoid; see additional Select Safety Information below
Under Medical Devices Rules DCGI classifies 112 anesthesiology devices
The Drug Controller General (India) has classified 112 medical devices related to anesthesiology, which is used in taking care of a patient before, during and after surgery, under Medical Devices Rules
ICMR invites letters of intent on venous thromboembolism
Venous thromboembolism is a common and potentially life-threatening condition. It is quoted as a major health problem and one of the most common preventable causes of hospital deaths.VTE has rarely evoked such consideration in India. It continues to be under diagnosed and undertreated
DCGI classifies 112 anesthesiology devices under Medical Devices Rules
The Drug Controller General (India) has classified 112 medical devices related to anesthesiology, which is used in taking care of a patient before, during and after surgery, under Medical Devices Rules
Ipsen and IRLAB announced the signing of a licensing agreement, providing Ipsen exclusive worldwide development and commercial rights to mesdopetam, a novel dopamine D3-receptor antagonist. Mesdopetam is being assessed in phase IIb clinical trials as a potential treatment option
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