CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment
If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe
If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe
The approval of this important test marks the 14th IVD to receive clearance by the CDSCO, and strengthens the company’s foundation for future growth
The tablets are available in 100 mg strength in bottle count sizes of 60
Targeted action improves quality of healing of tendon and suspensory ligament injuries in horses
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
The launch is yet another first of its kind innovation in India
Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies
The HD-550 endoscopy system has been available outside of the USA since 2019
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
This product will be manufactured at Lupin’s Nagpur facility in India
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
Ocular hypertension affects over 5% of all adults; the eye does not properly drain fluid, causing eye pressure to build up
The product will be manufactured at Lupin’s facility in Goa, India
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International
Immunocin, an Immuno-modulator drug, significantly reduced the risk of death in the Phase 3 clinical trial in adult patients with moderate-to-severe Covid-19
Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced
Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
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