EC approves GSK’s Zejula for advanced ovarian cancer treatment
Zejula (niraparib), developed by pharma giant GSK, has become the first polymerase (PARP) inhibitor approved as monotherapy in the EU for
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Regulatory
Janssen applies to FDA for New Indication of XARELTO® for Peripheral Artery Disease
The Janssen Pharmaceutical Companies of Johnson & Johnson revealed on Monday the submission of the supplemental New Drug Application (sNDA)
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AstraZeneca receives FDA authorisation to resume COVID-19 vaccine trial
AstraZeneca has confirmed that the U.S. FDA has authorised the resumption of Phase III clinical trials of the COVID-19 AZD1222
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FDA approves Roche’s Venclexta combos for acute myeloid leukaemia
Roche revealed on Monday that Venclexta ® (venetoclax) in conjunction with azacitidine or decitabine or low-dose cytarabine (LDAC) has been
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SYNLAB validates saliva sampling method for SARS-CoV-2 testing
SYNLAB, leading European provider of medical diagnostic solutions, has revealed the successful authorization of saliva sampling platform, another groundbreaking non-invasive
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AstraZeneca’s FARXIGA® gets designation for Chronic Kidney Disease
AstraZeneca’s FARXIGA® was granted Breakthrough Therapy Designation (BTD) in the U.S. for Chronic Kidney Disease, following the DAPA-CKD Phase III
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Janssen’s Golimumab gets FDA nod for pediatric use in Juvenile Arthritis
Janssen’s Golimumab, a human monoclonal antibody used as an immunosuppressive drug and sold under the brand name Simponi, has received
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Algernon gets FDA nod for human study of Ifenprodil for COVID-19
Algernon has received the FDA’s approval for the commencement of a Phase 2 and 3 human study of it’s repurposed
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Sunovion gets FDA nod for KYNMOBI™ as Parkinson’s Disease treatment
Sunovion has announced it has received approval from the FDA for KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the treatment of
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FDA issues emergency authorisation for remdesivir to treat COVID-19
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for emergency use of Gilead’s remdesivir
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