Samsung Bioepis, Biogen receive FDA approval for Lucentis biosimilar

By NS Healthcare Staff Writer

21 Sep 21

Byooviz is said to be the first ophthalmology biosimilar for Lucentis to receive FDA approval and was previously…

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FDA committee recommends EUA for Comirnaty booster dose

By NS Healthcare Staff Writer

20 Sep 21

The advisory committee has recommended booster dose of Pfizer and BioNTech’s mRNA Covid-19 vaccine Comirnaty in people aged…

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Celltrion’s Covid-19 antibody therapy approved in South Korea

By NS Healthcare Staff Writer

20 Sep 21

CT-P59 marks the first monoclonal antibody to receive full approval from Korean MFDS to treat patients with Covid-19

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Health Canada grants full approval for Moderna’s Covid-19 vaccine

By NS Healthcare Staff Writer

17 Sep 21

Health Canada approved the Moderna’s NDS-CV based on clinical data from the Phase 3 COVE study in more…

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Takeda’s Exkivity approved in US to treat EGFR mutation-positive NSCLC

By NS Healthcare Staff Writer

16 Sep 21

The US FDA has simultaneously approved Thermo Fisher Scientific’s NGS CDx to identify NSCLC patients eligible for treatment…

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Pfizer’s JAK inhibitor Cibinqo authorised in UK to treat atopic dermatitis

By NS Healthcare Staff Writer

13 Sep 21

Cibinqo (abrocitinib) is a once-daily oral JAK1 inhibitor indicated for the treatment of moderate to severe atopic dermatitis…

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Hetero gets DCGI nod for generic version of Roche’s tocilizumab to treat Covid-19

By NS Healthcare Staff Writer

07 Sep 21

Hetero will manufacture the drug at its facility in Hyderabad and commercialise it in India by the end…

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EMA begins evaluation of data on Comirnaty booster dose

By NS Healthcare Staff Writer

07 Sep 21

EMA’s human medicines committee (CHMP) is expected to undertake an accelerated assessment of data submitted by Pfizer and…

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BeiGene gets FDA approval for Brukinsa to treat Waldenström’s macroglobulinemia

By NS Healthcare Staff Writer

02 Sep 21

The US FDA approval of Brukinsa was based on results from the Phase 3 ASPEN trial, which evaluated…

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BioMarin’s Voxzogo approved in Europe to treat children with achondroplasia

By NS Healthcare Staff Writer

30 Aug 21

The EC approval is based on data from the vosoritide clinical development programme, including results from the Phase…

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