Shots: The approval is based on data from 2 pivotal studies i.e OSPREY & CONDOR evaluating the safety & diagnostic performance of Pylarify in patients with prostate cancer Results: 1st […]readmore
Tags : Injection
Shots: The P-III ASPEN-1 trial evaluating the efficacy and safety of DaxibotulinumtoxinA (either 125 unit or 250 unit dose) for injection vs PBO in adults with cervical dystonia, patients followed […]readmore
Shots: The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer The 1st study involves assessing […]readmore
Shots: Nevakar received US FDA’s approval to market Ephedrine Sulfate Injection (50mg/10 ml) in a ready to use vial presentation and it is the 1st approval under collaboration b\w Nevakar […]readmore
Shots: Mylan’s Remdesivir 100mg/vial Lyophilized Powder for Injection will be launched in India under brand name Desrem in Jul with INR 4,800 which is 80% less to the price of […]readmore
Shots: The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to […]readmore
Biotech
Cumberland Pharmaceuticals’ RediTrex (methotrexate) Injection Receives the US FDA’s Approval
Shots: The approval of RediTrex is done post no. of communications with the FDA and several amendments to the NDA submitted to the FDA in late 2018 Cumberland to launch […]readmore
Shots: Takeda is issuing a recall for all doses of Natpara for injection (25/50/75/100 mcg) in the US after the discussion with US FDA due to the potential for rubber […]readmore
Shots: The US FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea (2mg, single dose) sterilized prefilled syringe with its expected availability to the […]readmore
Shots: The approval is based on two P-III studies evaluating the diagnostic results of Gadavist enhanced cardiac MRI to assess myocardial perfusion and late gadolinium enhancement in adult patients with […]readmore