Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

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Glaucoma drug Vyzulta, psoriasis remedy Skilarence win insurance benefit

28 January 2022 - The government granted health insurance benefits for Bausch Health Korea’s glaucoma treatment Vyzulta (latanoprostene bunod) and ...

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Highlights from CHMP 24-27 January meeting

28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...

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Recommendations made by the PBAC – December 2021 intracycle meeting

28 January 2022 - Recommendations made by the PBAC in December 2021 relating to the listing of drugs on the PBS ...

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Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...

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TGA approves Tepmetko for patients with non-small-cell lung cancer

27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...

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The price of cystic fibrosis drugs is still too high

27 January 2022 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has decided that Kaftrio and Kalydeco for cystic fibrosis ...

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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...

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Oncopeptides withdraws withdrawal of first marketed drug

24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...

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Bimzelx (bimekizumab) approved in Japan for the Treatment of plaque psoriasis, generalised pustular psoriasis and psoriatic erythroderma

24 January 2022 - The third approval for bimekizumab worldwide reinforces UCB’s commitment to bring new treatment options to the global ...

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Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults

24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...

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FDA approves Nucala (mepolizumab) 40 mg pre-filled syringe for children with severe eosinophilic asthma

24 January 2022 - This approval allows for at home administration in patients 6-11 years old with severe eosinophilic asthma. ...

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Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva

24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...

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Chugai’s Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan

21 January 2022 - The approval is based on the results of several clinical studies in hospitalised patients with COVID-19. ...

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