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FDA approval of neffy (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis – ARS Pharmaceuticals

Written by | 10 Aug 2024

ARS Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced… read more.

Asciminib receives FDA priority review for newly diagnosed Ph+ CP-CML – Novartis

Written by | 9 Aug 2024

The FDA has granted priority review to asciminib (Scemblix) for the treatment of patients with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase (CP-CML)…. read more.

European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab) – UCB

Written by | 8 Aug 2024

UCB, a global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for two 320 mg device presentations of Bimzelx (bimekizumab). The pre-filled syringe and… read more.

FDA advisers call for review of perioperative lung cancer trials – AstraZeneca

Written by | 7 Aug 2024

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously called for a review of perioperative clinical trial designs in resectable non-small cell lung cancer (NSCLC) to include assessment… read more.

Vir Biotechnology to withdraw from infectious diseases research

Written by | 6 Aug 2024

Vir Biotechnology is cutting one-quarter of its workforce in a move away from infectious disease research. The company, which rose to prominence with its coronavirus antibody work in… read more.

CHMP recommends Yuvanci (macitentan + tadalafil) to treat pulmonary arterial hypertension – Johnson & Johnson

Written by | 5 Aug 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yuvanci, intended for the… read more.

Positive CHMP opinion for including Mpox real-world effectiveness data in European Marketing Authorization for smallpox and Mpox vaccine – Bavarian Nordic

Written by | 4 Aug 2024

Bavarian Nordic A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a type II… read more.

FDA Advisory Committee reviewed Imfinzi (durvalumab) for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results – AstraZeneca

Written by | 3 Aug 2024

The FDA’s Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoints of event-free survival (EFS) in the treatment of resectable non-small cell lung… read more.

European Commission approves Vabysmo (faricimab) for treatment of retinal vein occlusion – Roche

Written by | 2 Aug 2024

Roche announced that the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch… read more.

European Commission approves Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with hemophilia B – Pfizer

Written by | 1 Aug 2024

Pfizer Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe… read more.

CHMP recommends Vevizye (cyclosporine 0.05 in SFA) to treat dry eye disease – Novaliq GmbH

Written by | 31 Jul 2024

On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

FDA approves Leqselvi (deuruxolitinib) to treat Alopecia areata – Sun Pharma

Written by | 30 Jul 2024

Sun Pharmaceutical Industry announced that the FDA approved Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. Alopecia areata affects around 700,000 people… read more.

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