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FDA panel turns down Reata kidney disease drug in unanimous vote

The company's shares plummeted by more than 40% in early Thursday trading after taking a hit earlier in the week when the FDA released the documents that outlined its...

10 December 2021 news Alport syndrome | Drug

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Volume 4 Issue 4

5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch, presents ...

9 December 2021 Volume 4 Issue 4 aspirin | FDA

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FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The Food and Drug Administration on Friday authorized COVID-19 booster shots for all vaccinated Americans over 18, a move that's meant to stem a rise in coronavirus i...

26 November 2021 news boosters | COVID-19

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Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy

The FDA's acceptance of Bluebird's application, which comes two months after the company submitted it to the agency, marks the final stretch of a long road for the tr...

26 November 2021 news Bluebird | FDA

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Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

The results disclosed by Pfizer and BioNTech on Monday could support full approvals in the U.S. and elsewhere, which in turn could help bolster vaccination rates amon...

26 November 2021 news BioNTech | COVID-19 vaccine

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Takeda wins US approval for new CMV treatment

Livtencity is part of the first wave of new products Takeda hopes will reposition the company as a top player in the pharmaceutical industry for years to come. Earlie...

26 November 2021 news CMV | drugmaker

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Biden nominates Robert Califf to return as FDA head

If confirmed, the cardiologist would return to lead an agency taxed by a heavy workload reviewing COVID-19 drugs and vaccines. President Joe Biden on Friday nominate...

19 November 2021 news Biden | FDA

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Pfizer asks FDA to authorize COVID-19 pill

Pfizer's pill is the second oral drug for COVID-19 to be proven strongly effective in large, placebo-controlled clinical trials after Merck's molnupiravir, which earl...

19 November 2021 news clinical trials | COVID-19 pill

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Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19. Pfizer and ...

15 November 2021 news adults | BioNTech

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FibroGen cuts jobs as it weighs anemia drug’s future in US

The upcoming FDA meeting is critical for FibroGen. CEO Enrique Conterno told analysts on a conference call this week that he believes the company has a "good proposal...

15 November 2021 news anemia | AstraZeneca

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FDA panel turns down Reata kidney disease drug in unanimous vote

5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy

Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

Takeda wins US approval for new CMV treatment

Biden nominates Robert Califf to return as FDA head

Pfizer asks FDA to authorize COVID-19 pill

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

FibroGen cuts jobs as it weighs anemia drug’s future in US

International Biopharmaceutical Industry