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European Commission approves Wyost (denosumab) and Jubbonti (denosumab) which are the first and only biosimilars of denosumab in Europe – Sandoz

Written by | 30 May 2024

Sandoz, the global leader in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Wyost (C) and Jubbonti (denosumab), the first and… read more.

Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm

Written by | 29 May 2024

Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to Humira (adalimumab), in the… read more.

Breyanzi (lisocabtagene maraleucel) approved by the FDA for relapsed or refractory follicular lymphoma – BMS

Written by | 28 May 2024

Bristol Myers Squibb announced the FDA has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of… read more.

Eisai initiates rolling biologics license application to FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the Fast Track status

Written by | 27 May 2024

-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.

Approval of Augtyro (repotrectinib) for patients with ROS1-positive NSCLC by China’s NMPA – Zai Lab

Written by | 26 May 2024

Zai Lab Limited announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for Augtyro (repotrectinib) for the treatment of adult… read more.

Publication in The Lancet is announced of phase III bimekizumab trials in moderate to severe hidradenitis suppurativa – UCB

Written by | 25 May 2024

UCB, announced that The Lancet has published results from the Phase III BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab, an… read more.

FDA approves Imdelltra (taralatamab-dlle),the first and only T cell engager therapy to treatextensive stage small cell lung cancer – Amgen

Written by | 24 May 2024

Amgen announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after… read more.

Extension of FDA review period for TransCon PTH for adults with hypoparathyroidism – Ascendis Pharma

Written by | 23 May 2024

Ascendis Pharma A/S announced that the FDA notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon… read more.

New four-Year Sotyktu (deucravacitinib) data demonstrates durable response rates and consistent safety in moderate-to-severe plaque psoriasis – BMS

Written by | 22 May 2024

Bristol Myers Squibb announced new four-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. After four… read more.

Fycompa (perampanel hydrate) is approved in China for adjunctive treatment of primary generalised tonic-clonic seizures – Eisai

Written by | 21 May 2024

Eisai announces approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (generic name: perampanel hydrate) for adjunctive treatment of primary generalized tonic/clonic… read more.

Updates from SCORPIO-HR, a global phase III study of ensitrelvir for non-hospitalized participants with COVID-19 – Shionogi

Written by | 20 May 2024

Shionogi & Co., Ltd. announced that its pivotal, double-blind, randomized, placebo-controlled global Phase III study (SCORPIO-HR) did not meet its primary endpoint of a statistically significant reduction in… read more.

Regulatory update on sBLA for four-dose Heplisav-B regimen for adults on hemodialysis in the US – Dynavax Technologies

Written by | 19 May 2024

Dynavax Technologies Corporation provided a regulatory update for the Company’s supplemental Biologics License Application (sBLA) to include a four-dose Heplisav- B vaccine [Hepatitis B Vaccine (Recombinant),Adjuvanted] regimen for… read more.

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