Food and Drug Administration - International Biopharmaceutical Industry

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Lilly pours more money into genetic treatments for neurological diseases

With its potential to treat an enormous range of diseases, genetic medicine has become a focal point for many large drug companies. Novartis, for instance, just last ...

7 January 2022 news Food and Drug Administration | genetic medicine

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Biogen reserves four years for trial meant to confirm its Alzheimer’s drug works

A crucial study evaluating Biogen's approved drug for Alzheimer's disease is set to begin in May, the company disclosed Thursday, and if enrollment goes as expected, ...

16 December 2021 news Aduhelm | Alzheimer

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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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New Merck study results raise questions about its COVID pill

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug. New study results disclosed by...

3 December 2021 news COVID-19 pill | Food and Drug Administration

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Biogen seeking more information in investigation of Aduhelm patient’s death

Aduhelm has come under intense scrutiny since the Food and Drug Administration's controversial June approval of the drug, the first new Alzheimer's treatment in decad...

26 November 2021 news Aduhelm | Alzheimer

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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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Anticipating Aduhelm’s costs, Medicare plans big jump in premiums

The decision affects Medicare Part B, which pays for health care services typically received outside of institutional settings like hospitals and nursing homes. The p...

19 November 2021 news Aduhelm | Alzheimer

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Amylyx asks FDA to approve ALS drug, while also preparing late-stage study

Amylyx Pharmaceuticals has officially asked the Food and Drug Administration to approve its experimental and closely watched medicine for ALS. Now, the FDA has aroun...

8 November 2021 news ALS | AMX0035

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Merck wins UK authorization to sell first COVID-19 pill

U.K. regulators have once again moved faster than the Food and Drug Administration to approve a new medicine for COVID-19. The UK's Medicines and Healthcare products ...

8 November 2021 news COVID-19 | FDA

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Merck agrees to license COVID-19 pill widely through pact with patent group

Merck's pill has the potential to alter the course of the pandemic. Earlier this month, the company and partner Ridgeback Biotherapeutics released data showing molnup...

29 October 2021 news COVID-19 | COVID-19 pill

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