Trump pressed for plasma therapy. Officials worry, is an unvetted vaccine next?

12 September 2020 - New details of how the president has demanded faster action from health agencies help explain the intensifying ...

Read more →

Junshi Biosciences receives FDA breakthrough therapy designation for toripalimab for the treatment of nasopharyngeal carcinoma

10 September 2020 - Junshi Biosciences announced today that the US FDA has recently granted breakthrough therapy designation to toripalimab for ...

Read more →

Terns Pharmaceuticals receives fast track designation for TERN-201 as a treatment for NASH

10 September 2020 - Clinical trial of semicarbazide-sensitive amine oxidase inhibitor TERN-201 in NASH patients planned for early 2021. ...

Read more →

China debates cutting US access to drugs as hostilities spike

10 September 2020 - Some government advisers say China should cut drug exports to the US if Washington increases sanctions. ...

Read more →

COVID-19 drug rationed in the US is plentiful in developing countries

9 September 2020 - During the coronavirus surge in Texas this summer, Dr. Thomas Patterson said he only had enough ...

Read more →

Pfizer may win the COVID vaccine race. But distributing it could be another matter.

10 September 2020 - Needing deep-freeze storage could complicate a massive rollout. ...

Read more →

FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision

10 September 2020 - The head of the FDA said he has “no intention” of overruling career scientists at the agency ...

Read more →

Majority of Americans believe political pressure will cause FDA to rush a coronavirus vaccine, new poll finds

10 September 2020 - A majority of Americans, 62%, believe political pressure from the Trump administration will cause the US ...

Read more →

‘Hell has frozen over’: The pharmaceutical industry stands in for a politically impaired FDA

10 September 2020 - How can Americans tell when the FDA has become so politically impaired that it cannot serve ...

Read more →

Halozyme announces Janssen submission for FDA approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of patients with light chain amyloidosis

10 September 2020 - Follows FDA approval of Darzalex Faspro utilising Enhanze technology in May 2020 for the treatment of patients ...

Read more →

Vaccine developers hustle to meet FDA data requirements to submit for approval

10 September 2020 - There are many questions regarding the approval of a potential COVID-19 vaccine. ...

Read more →

FDA approves Trelegy Ellipta as the first once daily single inhaler triple therapy for the treatment of both asthma and COPD in the US

9 September 2020 - New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment ...

Read more →

Some good news on COVID-19

9 September 2020 - The virus seems to generate a robust and fairly long-lasting immune response. ...

Read more →

‘You can’t rush science’ — Merck CEO stresses need for careful approach to coronavirus vaccine

9 September 2020 - Frazier’s Merck was among the nine companies that signed a pledge to prioritise safety as the drugmakers ...

Read more →

Clarity Pharmaceuticals announces the US FDA grants rare paediatric disease designation to 64 Cu sartate, a diagnostic for the clinical management of neuroblastoma

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

Read more →