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As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

The FDA has been under pressure to review the status of drugs granted accelerated approvals based on early data, as in some cases confirmatory trials haven't been com...

30 September 2021 news AstraZeneca | Bristol Myers Squibb

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FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

While the clinical hold lifting is encouraging news for the companies' partnership, questions still loom about safety in the genetic medicine field. Earlier this mont...

30 September 2021 news Angelman | FDA

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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 consideri...

30 September 2021 news BioCentury | COVID-19

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Takeda wins FDA approval for targeted lung cancer drug

In the midst of a years-long makeover, Takeda is looking to new products such as Exkivity to shore up future growth and cement its place as a major player in the phar...

17 September 2021 news FDA | lung cancer

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Galapagos CEO to retire, though successor yet to be announced

Galapagos looked to be in a strong position at the start of 2020. It had recently closed a major research deal with Gilead that not only provided substantial amounts ...

3 September 2021 news drug development | FDA

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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 ...

27 August 2021 news BioNTech | coronavirus vaccine

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AstraZeneca reports study success for rare disease drug acquired in Alexion deal

Should detailed study results bear out ALXN1480's benefit and lead to an FDA approval, the experimental drug could become an important new option for people with Wils...

27 August 2021 news Alexion | ALXN1480

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FDA clears Rocket to resume testing gene therapy for a rare heart disease

Rocket's program has been in limbo since early May, when the company surprised investors and analysts with news of the trial's stoppage. That announcement stalled wh...

20 August 2021 news Bluebird | FDA

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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

The U.S. health department's inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investig...

13 August 2021 news Aduhelm | Alzheimer

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In a first, FDA approves an ‘interchangeable’ biosimilar for diabetes

The promise of biosimilars — that competition would bring down the prices of complex biological drugs — hasn't materialized in the U.S. in the way many expected. Comp...

5 August 2021 news ABBVIE | Amgen

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As FDA scrutinizes immunotherapy approvals, Merck says Keytruda extends survival in liver cancer trial

FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

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

Takeda wins FDA approval for targeted lung cancer drug

Galapagos CEO to retire, though successor yet to be announced

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

AstraZeneca reports study success for rare disease drug acquired in Alexion deal

FDA clears Rocket to resume testing gene therapy for a rare heart disease

HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

In a first, FDA approves an ‘interchangeable’ biosimilar for diabetes

International Biopharmaceutical Industry