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Former Immunomedics executive charged with insider trading around trial data

Early in the spring of 2020, Immunomedics was waiting for the Food and Drug Administration to decide on accelerated approval of the company's breast cancer therapy. I...

13 December 2021 news FDA | Food and Drug Administration

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Biohaven to seek FDA approval for second migraine drug after study success

While a smaller biotech company, Biohaven has succeeded in a market led by large pharmaceutical firms like Lilly, AbbVie and, in the preventive treatment setting, Amg...

10 December 2021 news ABBVIE | Amgen

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AstraZeneca antibody cleared by FDA for preventive use against COVID-19

AstraZeneca's drug, called Evusheld, is the fifth COVID-19 antibody treatment authorized by the FDA, and the fourth now available after Lilly pulled one of its two me...

10 December 2021 news antibody treatment | AstraZeneca

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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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