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- PMLiVE

Cornerstone

- PMLiVE

Biosimilars boosted by FDA’s landmark ruling for Boehringer’s Cyltezo

The FDA has approved Boehringer’s Cyltezo (adalimumab-adbm) as ‘interchangeable’ with Humira (adalimumab) in a landmark ruling

regeneron headquarters

FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

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AstraZeneca requests Emergency Use Authorization from FDA for COVID-19 antibody

Phase 3 data shows the long-acting antibody combination produces a 77% reduction in the risk of developing symptomatic COVID-19

Biogen Idec building

Rocky start for Biogen’s Alzheimer’s drug Aduhelm

Controversial Alzheimer’s treatment Aduhelm is struggling to realise its potential, with only 100 patients receiving the therapy so far in the US

- PMLiVE

COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

- PMLiVE

FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

- PMLiVE

Sanofi boosts transplant portfolio with newly approved Rezurock

Sanofi’s acquisition of Kadmon Holdings adds Rezurock to its transplant portfolio in a deal worth $1.9bn.

Biomarin

FDA pauses BioMarin gene therapy trial

The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

- PMLiVE

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

- PMLiVE

FDA experts to evaluate Pfizer-BioNTech COVID-19 booster

As Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time

- PMLiVE

FDA nod for Janssen schizophrenia treatment Invega Hafyera

The phase 3 study results showed that 92% of patients were relapse-free after 12 months

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