Submissions and Approvals

India Approves Biocon’s Psoriasis Drug as COVID-19 Treatment

July 13, 2020

A clinical trial in Mumbai and New Delhi showed the treatment reduced the mortality rate. Read More

Pfizer and BioNTech Nab Fast Track Status for Two COVID-19 Vaccines

July 13, 2020

Moderna earned a fast track designation for its vaccine candidate in May. Read More

NICE Backs Takeda’s Adcetris for Rare Lymphoma

July 13, 2020

The agency said Adcetris is likely to be cost-effective for use by the National Health Service for treatment of the rare lymphoma. Read More

AstraZeneca Gets Priority Review for Brilinta to Reduce Subsequent Strokes

July 13, 2020

The agency approved Brilinta in May to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease. Read More

Australia Approves Remdesivir for Severe COVID-19 Patients

July 13, 2020

The provisional approval is good for six years. Read More

FDA Approves Sixth Humira Biosimilar

July 10, 2020

The FDA has handed Mylan and Fujifilm Kyowa Kirin Biologics approval for their biosimilar of Humira (adalimumab), marking the agency’s sixth approval for a biosimilar of AbbVie’s blockbuster immunosuppressive drug. Read More

Osmotica Receives FDA Approval for Droopy Eyelid Treatment

July 10, 2020

Osmotica plans to launch Upneeq next month through a select group of ophthalmologists and optometrists. Read More

FDA Approves Mylan and Fujifilm’s Humira Biosimilar

July 10, 2020

Mylan will launch the biosimilar in July 2023. Read More

Lynparza Receives European Approval for Pancreatic Cancer

July 9, 2020

Lynparza is currently approved in the U.S. and several other countries for the same indication. Read More

Biogen Submits BLA for Alzheimer’s Treatment Aducanumab

July 9, 2020

The FDA has 60 days to decide whether to accept the application. Read More

ViiV Healthcare’s Rukobia Approved for Previously-Treated HIV

July 7, 2020

Rukobia was granted fast track, priority review and breakthrough therapy designations by the FDA. Read More

Nabriva Hit With a Second Complete Response Letter for Antibiotic

July 6, 2020

Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Read More

Submissions and Approvals
RSS

India Approves Biocon’s Psoriasis Drug as COVID-19 Treatment

Pfizer and BioNTech Nab Fast Track Status for Two COVID-19 Vaccines

NICE Backs Takeda’s Adcetris for Rare Lymphoma

AstraZeneca Gets Priority Review for Brilinta to Reduce Subsequent Strokes

Australia Approves Remdesivir for Severe COVID-19 Patients

FDA Approves Sixth Humira Biosimilar

Osmotica Receives FDA Approval for Droopy Eyelid Treatment

FDA Approves Mylan and Fujifilm’s Humira Biosimilar

Lynparza Receives European Approval for Pancreatic Cancer

Biogen Submits BLA for Alzheimer’s Treatment Aducanumab

ViiV Healthcare’s Rukobia Approved for Previously-Treated HIV

Nabriva Hit With a Second Complete Response Letter for Antibiotic

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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