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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.

Four year data for Wegovy (semaglutide) in obesity presented at ECO meeting and published in Nature – Novo Nordisk

Written by | 18 May 2024

At the European Congress on Obesity in Venice, investigators unveiled results from an analysis published in Nature Medicine evaluating Wegovy’s weight loss benefits over four years. With this… read more.

Phase III CheckMate-73L trial did not meet its primary endpoint in stage III non-small cell lung cancer – BMS

Written by | 17 May 2024

Bristol Myers Squibb announced the Phase III CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell… read more.

National approvals in all EU countries for MOB 15 to treat mild to moderate fungal infections of the nails – Moberg Pharma

Written by | 16 May 2024

Moberg Pharma AB hereby announces that MOB 015 has received national approvals for all countries included in the decentralized procedure. MOB 015 is thus approved for the treatment… read more.

Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH – Sobi

Written by | 15 May 2024

Sobi has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) for treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have… read more.

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