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Food and Drug Administration

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, …

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Aduhelm

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 …

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FDA

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 …

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COVID-19 pill

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 …

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Aduhelm

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 decades …

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boosters

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 …

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Aduhelm

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 planned …

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ALS

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 around …

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COVID-19

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 …

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COVID-19

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 molnupiravir …

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19-64 age

CDC panel levels playing field for new Merck, Pfizer pneumonia vaccines

This is the first time government advisers have recommended routine use of a pneumococcal vaccine for certain risk groups within the 19-64 age bracket, a …

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BioCentury

Top FDA official takes over vaccine office as agency weighs COVID-19 shots for kids

Peter Marks, one of the Food and Drug Administration’s top-ranking officials, has taken over the agency’s vaccine review office just as the regulator begins considering …

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coronavirus

After coronavirus success, J&J hits setback with HIV vaccine

Before J&J become one of three companies that earned Food and Drug Administration approval for a coronavirus vaccine, the pharma was already a leader in …

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BioNTech

FDA grants full approval to Pfizer, BioNTech’s coronavirus vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech’s coronavirus vaccine, a long-awaited decision that government officials hope could help …

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