Regulatory

60 Degrees Pharmaceuticals Halts Tafenoquine COVID-19 Trial in Response to FDA Recommendations

In accordance with FDA guidance, 60 Degrees Pharmaceuticals has opted to halt the Phase IIb trial for tafenoquine, known as ACLR8-LR. This...

UCB’s Psoriasis Drug Application Faces a Further FDA Delay

In May of this year, the FDA issued a full response letter that delayed the launch of UCB's bimekizumab treatment for psoriasis...

FDA Gives Green Light to GSK’s Innovative Bone Cancer Drug, Validating Billion-Dollar Investment

The Food and Drug Administration (FDA) has granted approval for GSK's groundbreaking treatment for myelofibrosis, a form of bone marrow cancer, signifying...

FDA Issues Warning to 8 Companies Selling Illegal Eye Drugs

The Food and Drug Administration (FDA) said on Tuesday that it is taking action against eight different firms because it believes they...

Scientists successfully grow part-human part-pig kidneys to solve transplant crisis

Researchers have successfully cultivated part-human, part-pig kidneys within pig embryos, ushering in a new era of organ transplantation possibilities. 

Ahead of the seasonal spike, Pfizer and BioNTech’s Covid vaccine receives FDA greenlight

The U.S. FDA has taken a significant step by approving modified mRNA vaccines for COVID-19 from Pfizer-BioNTech and Moderna while discontinuing the...

European Commission Approves Updated Pfizer-BioNTech Vaccine for Omicron XBB.1.5 Variant

The European Commission has recently achieved a significant milestone in the ongoing battle against COVID-19 in preparation for the upcoming autumn and...

NICE gives Chiesi’s Elfabrio go ahead

Chiesi has recently garnered a favorable recommendation from the National Institute for Health and Care Excellence (NICE) in relation to their cutting-edge...

Latest news

60 Degrees Pharmaceuticals Halts Tafenoquine COVID-19 Trial in Response to FDA Recommendations

In accordance with FDA guidance, 60 Degrees Pharmaceuticals has opted to halt the Phase IIb trial for...

Phase 3 trial data for Astellas’s GA drug yielded positive results

A mere six weeks after obtaining FDA approval, Astellas Pharma is already considering expanding the label for...

UCB’s Psoriasis Drug Application Faces a Further FDA Delay

In May of this year, the FDA issued a full response letter that delayed the launch of...

Must read

Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

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Revolo Reveals Positive Midphase Data For EoE Candidate

Revolo Biotherapeutics believes that it possesses the...

Novavax breaks production contract with Fujifilm, pays $185 Million

 Following an FDA approval this summer, Novavax...