The FDA should not rush a COVID-19 vaccine

2 June 2020 - Vaccines are widely expected to offer the best way out of the COVID-19 pandemic.  ...

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Clarity Pharmaceuticals announces that the US FDA grants rare paediatric disease designation to Copper Cu 67 sartate for the treatment of neuroblastoma

3 June 2020 - Clarity Pharmaceuticals is pleased to announce that the U.S. FDA has granted rare paediatric disease designation to ...

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Antimicrobial approvals are not bottlenecked by FDA

3 June 2020 - Sponsors seeking US FDA approval for anti-microbial drugs accessed expedited clinical testing and review programs at least ...

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Law makers, government watchdog blast FDA for poor oversight of U.S. drug supply chain

2 June 2020 - A government watchdog blasted the FDA for fumbling its oversight of the safety of the U.S. ...

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Hahn: FDA will make some changes amid COVID-19 permanent

1 June 2020 - The US FDA will look to permanently implement some of the processes and policies adopted in ...

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Zoloft falls into shortage as virus anxiety strains supplies

2 June 2020 - Drug makers blame increase in demand and ingredient shortfall. ...

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The CDC waited its entire existence for this moment. What went wrong?

3 June 2020 - Americans returning from China landed at U.S. airports by the thousands in early February, potential carriers ...

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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...

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Helsinn Group announces FDA approval of a new liquid formulation of Akynzeo (fosnetupitant/palonosetron) injection in the United States

2 June 2020 - Helsinn today announces that the U.S. FDA has approved the ready-to-dilute liquid formulation of Akynzeo (fosnetupitant/palonosetron) ...

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Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review

2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...

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European Commission approves Sarclisa (isatuximab) for adults with relapsed and refractory multiple myeloma

2 June 2020 - EC approval based on data from first randomised Phase 3 trial (ICARIA-MM) to report results evaluating an ...

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Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...

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Health Canada advises Canadians to help support the continued supply of medications

1 June 2020 - Health Canada recognizes that drug shortages can have a significant impact on patients and health care ...

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Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids

1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...

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AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma

1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...

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