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Johnson & Johnson statement on COVID 19 vaccine

Written by | 21 Apr 2021

Johnson & Johnson Statement on COVID-19 Vaccine (Updated) :The safety and well-being of the people who use our products is a number one priority. We are aware of… read more.

Melflufen filed with EMA for multiple myeloma – Oncopeptides AB

Written by | 20 Apr 2021

Oncopeptides AB announced that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based… read more.

Hypothesis for rare side effect linked to AstraZeneca vaccine

Written by | 19 Apr 2021

A hypothesis has been put forward as to why COVID-19 Vaccine AstraZeneca (ChAdOx1 nCov-19) seems to trigger an abnormal and potentially life-threatening combination of blood clotting and low… read more.

FDA approves Trodelvy, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival – Gilead Sciences

Written by | 18 Apr 2021

Gilead Sciences, Inc. announced that the FDA has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)… read more.

FibroGen provides additional information on roxadustat to the FDA relating to U.S. primary cardiovascular safety analyses

Written by | 17 Apr 2021

FibroGen, Inc. has provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase III program for the treatment of anemia of chronic… read more.

Complete Response Letter for sBLA for Keytruda in high-risk early-stage triple-negative breast cancer (TNBC) – Merck Inc.

Written by | 16 Apr 2021

Merck Inc., announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) seeking approval for Keytruda, the company’s anti-PD-1 therapy,… read more.

Evrysdi approved by European Commission as first and only at home treatment for spinal muscular atrophy – Roche

Written by | 15 Apr 2021

Roche announced that the European Commission (EC) has approved Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older,… read more.

EU approves SC version of Tysabri for multiple sclerosis – Biogen

Written by | 14 Apr 2021

Biogen announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).

FDA approval of additional indication for Vyxeos for the treatment of secondary acute myeloid leukemia in pediatric patients – Jazz Pharma

Written by | 13 Apr 2021

Jazz Pharmaceuticals plc has announced that the FDA approved a revised label for Vyxeos (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid… read more.

New real-world observational analysis of Uptravi underscores the importance of risk assessment for treating pulmonary arterial hypertension patients -Johnson & Johnson

Written by | 12 Apr 2021

Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found more than three-quarters (76%) of pulmonary arterial hypertension… read more.

FDA approves Qelbree for attention-deficit hyperactivity disorder in pediatric patients – Supernus Pharmaceuticals

Written by | 10 Apr 2021

Supernus Pharmaceuticals announced that the FDA approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age…. read more.

AZD 1222 US phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis – AstraZeneca

Written by | 9 Apr 2021

The AstraZeneca US Phase III trial of AZD 1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and… read more.

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