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Long-term data from PACIFIC phase III trial at ASCO showed 33% of NSCLC patients remained progression-free at five years – AstraZeneca

Written by | 9 Jun 2021

Updated results from the positive PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit at five… read more.

Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis

Written by | 8 Jun 2021

Novartis,has announced the FDA has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for… read more.

Nefecon filed with EMA for primary IgA Nephropathy – Calliditas Therapeutics

Written by | 7 Jun 2021

Calliditas Therapeutics has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Nefecon (budesonide), a novel oral formulation targeting down regulation of IgA1 for… read more.

Scynexis announces FDA approval of Brexafemme as the first and only oral non-azole treatment for vaginal yeast infections

Written by | 6 Jun 2021

Scynexis Inc.,. announced that the FDA has approved Brexafemme(ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Brexafemme which represents… read more.

Organon launches as new global women’s health company

Written by | 5 Jun 2021

Organon celebrates its launch as a global women’s health company with employees and women from around the world, as the Organon executive leadership team rings the opening bell… read more.

European Commission approval for Venclyxto + a hypomethylating agent for newly diagnosed acute myeloid leukemia – AbbVie

Written by | 3 Jun 2021

AbbVie announced that the European Commission (EC) has approved Venclyxto (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly… read more.

FDA approves Lybalvi for schizophrenia and bipolar I disorder – Alkermes

Written by | 2 Jun 2021

Alkermes announced that the FDA has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder,… read more.

Health Canada approves Abecma for multiple myeloma – BMS

Written by | 2 Jun 2021

Bristol Myers Squibb Canada announced Health Canada has granted conditional approval (NOC/c) for Abecma (idecabtagene vicleucel; ide-cel) as the first and only B-cell maturation antigen (BCMA)-directed chimeric antigen… read more.

Lantheus receives FDA approval of Pylarify injection, the first and only commercially available PSMA PET imaging agent for prostate cancer

Written by | 1 Jun 2021

Lantheus Holdings, Inc. announced that the FDA has approved Pylarify, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent to identify suspected metastasis… read more.

European Commission approves Ponvory a once daily, oral therapy for the treatment of relapsing forms of multiple sclerosis – Janssen

Written by | 31 May 2021

Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced that the European Commission (EC) has approved Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis… read more.

MHRA approves Ad26.COV2-S [recombinant] for active immunisation against COVID-19 within the United Kingdom – Janssen

Written by | 30 May 2021

Ad26.COV2-S [recombinant] a single-dose coronavirus vaccine from Janssen, part of Johnson & Johnson, has been approved by the MHRA (UK) and is indicated for active immunisation to prevent… read more.

Intercept Pharmaceuticals Inc. announces updates to Ocaliva prescribing information for primary biliary cholangitis

Written by | 29 May 2021

Intercept Pharmaceuticals, Inc. announced that the Ocaliva (obeticholic acid or OCA) Prescribing Information in the United States has been updated.The changes to the Ocaliva Prescribing Information were prompted… read more.

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