Medical Communications

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CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment

March 22, 2024 Medical Communications CHMP, Diabetes, Novo Nordisk, diabetes

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended …
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MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment

March 21, 2024 Medical Communications Hyqvia, MHRA, Neurology, Takeda, chronic inflammatory demyelinating polyneuropathy

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a …

Boehringer Ingelheim’s Spevigo gains additional approvals in US and China

March 20, 2024 Medical Communications Boehringer Ingelheim, Dermatology, FDA, Spevigo, psoriasis

Boehringer Ingelheim has announced that Spevigo (spesolimab-sbzo) has been approved by the US Food and Drug Administration (FDA) for the …

FDA approves first treatment for liver scarring due to fatty liver disease

March 15, 2024 Medical Communications Endocrinology, FDA, fatty liver disease, liver scarring, nash

The US Food and Drug Administration (FDA) has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult …

BeiGene’s Brukinsa gains FDA accelerated approval for follicular lymphoma treatment

March 8, 2024 Medical Communications BeiGene, Brukinsa, FDA, Oncology, follicular lymphoma

BeiGene has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa (zanubrutinib) for the …

FDA approves Sandoz’s denosumab biosimilars

March 6, 2024 Medical Communications FDA, Jubbonti, Musculo-skeletal disorder, Sandoz, Wyost, denosumab

Sandoz has announced that the US Food and Drug Administration (FDA) has approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), which are …

GSK’s Jemperli recommended by NICE for endometrial cancer treatment

March 5, 2024 Medical Communications GSK, Jemperli, NICE, Oncology, endometrial cancer

GSK has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Jemperli (dostarlimab) …

FDA approves J&J’s Rybrevant with chemotherapy for NSCLC treatment

March 4, 2024 Medical Communications FDA, Johnson & Johnson, NSCLC, Oncology, Rybrevant

Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved Rybrevant (amibantamab-vmjw) following a priority …
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EMA validates two applications for datopotamab deruxtecan for cancer treatments

March 4, 2024 Medical Communications CHMP, Daiichi Sankyo, EMA, Oncology, datopotamab deruxtecan

AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications (MAAs) for AstraZeneca and Daiichi …

Viracta Therapeutics completes enrolment for T-cell lymphoma cohort in NAVAL-1 trial

March 1, 2024 Medical Communications Oncology, Viracta Therapeutics, lymphoma

Viracta Therapeutics has announced that it has completed stage 2 enrolment into the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) …

AstraZeneca’s Voydeya recommended for approval in EU by CHMP

February 29, 2024 Medical Communications AstraZeneca, CHMP, EMA, Haematology, Voydeya

AstraZeneca has announced that Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) by the Committee …

Spero Therapeutics’ bacterial infection treatment gains FDA IND clearance

February 29, 2024 Medical Communications FDA, Infections and infestations, Spero Therapeutics, bacterial infections, investigational new drug

Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug …

FDA accepts BLA for Regeneron’s linvoseltamab for Priority Review

February 22, 2024 Medical Communications FDA, Oncology, Regeneron, bla, priority review

Regeneron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for …

Pfizer’s Velsipity approved by EC for ulcerative colitis treatment

February 20, 2024 Medical Communications European Commission, Gastrointestinal tract, Pfizer, Velsipity, ulcerative colitis

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Velsipity (etrasimod) in the European Union (EU). …

argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment

February 20, 2024 Medical Communications CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA

argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for …
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