FDA+ channel feed – Endpoints News

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Biogen narrows its Aduhelm label after FDA left the floodgates open

4 years ago

In pursuit of a blockbuster, Amgen and AstraZeneca score priority review for asthma drug tezepelumab

4 years ago

Oncopeptides says a second look at its data offers a win in head-to-head cancer trial — but key OS flop triggers a hold

4 years ago

FDA shoots down petition to stall generic versions of Bristol Myers' blockbuster chemo Abraxane

4 years ago

Rep. Porter calls on HHS inspector general to investigate FDA-Biogen ties prior to Aduhelm's approval

4 years ago

Opinion: The FDA's mRNA vaccine full approval reviews are moving plenty fast. Start the mandates now

4 years ago

Guidance bonanza: FDA, EMA, MHRA, Health Canada and PIC/S offer new advice on a range of pharma issues

4 years ago

Down but not out: FDA rejects Provention's diabetes drug as commercial product differs from trial drug

4 years ago

Duke to host private meeting with payers and biopharma on how to pay for Alzheimer's drugs

4 years ago

Merck to withdraw dangling accelerated approval for Keytruda in third-line stomach cancer

4 years ago

Roche mulling quick filing for a tarnished Alzheimer’s drug as controversial Aduhelm OK electrifies the field — analyst

4 years ago

Patient experience data in regulatory decisions: Questions abound in first FDA report

4 years ago

Jazz's reworked narcolepsy drug wins 7 years of orphan exclusivity thanks to rare 'clinical superiority' finding from FDA

4 years ago

FDA and Biogen discussed Aduhelm's accelerated approval as early as 2019 — report

4 years ago

'Biased and misleading': No holds barred in FDA's statistical review of Biogen's Aduhelm

4 years ago

The FDA has now poked a hornet's nest of controversy in the House. And that could sting Biogen's mega blockbuster quest in Alzheimer's

4 years ago

EU regulatory committee recommends 8 new drugs for approval, including Bristol Myers' BCMA CAR-T

4 years ago

US pauses use of Eli Lilly's Covid-19 treatment nationwide due to variants

4 years ago

FDA pushes back decisions on AbbVie's Rinvoq sNDAs to further review a failed Pfizer trial

4 years ago

Mirati steps on the gas with KRAS inhibitor, looking to claim second approval behind Amgen's Lumakras

4 years ago

House draft 2022 spending bill: $86M less for FDA than what Biden requested

4 years ago

ODAC echoes FDA concern over Incyte PD-1, as Pazdur signals broader shift for accelerated approval

4 years ago

FDA encourages including incurable cancer patients in trials, regardless of prior therapies

4 years ago

Senators call for hearing to examine how Medicare will handle Biogen's new Alzheimer's drug

4 years ago

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