FDA+ channel feed – Endpoints News

FDA+ channel feed

Just as first Lucentis biosimilar wins approval, Roche snags an OK for an easier route of administration

4 years ago

Oncopeptides stock craters as it pulls cancer drug Pepaxto from the market

4 years ago

FDA says benefits of Covid-19 vaccine for younger children outweigh risks

4 years ago

Agenus calls out FDA for playing favorites with Merck, pulls cervical cancer BLA at agency's request

4 years ago

FDA rejects United's potential PAH drug due to a manufacturing issue

4 years ago

How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance

4 years ago

Senators back FDA's plan to require mandatory prescriber education for opioids

4 years ago

FDA slaps AstraZeneca's MCL-1 cancer drug with a hold after safety issue — 2 years after Amgen axed a troubled rival

4 years ago

FDA shoots down a biotech’s last-stand patient pitch after faulting data

4 years ago

FDA warns Minnesota doc for running two ketamine trials without INDs, and with children and a pregnant woman

4 years ago

With hundreds of millions spent on failed accelerated approvals, researchers call for faster FDA withdrawals

4 years ago

Senate spending bill slashes funds for Biden's planned breakthrough drug accelerator at NIH

4 years ago

FDA OKs an inhaled version of smoking cessation drug Chantix — for a common eye disease

4 years ago

Omeros plunges deeper after FDA rejects rare disease drug, asking for more information

4 years ago

Third time's the charm: Adamis nabs approval of high-dose naloxone injection after two CRLs

4 years ago

FDA rejects Revance's pitch for Botox competitor as biotech blames manufacturing issues

4 years ago

Boehringer nabs FDA's first interchangeability designation for its Humira competitor — but will it matter?

4 years ago

Roche's Tecentriq crosses the finish line first in adjuvant lung cancer, potentially kicking off gold rush

4 years ago

FDA adcomm votes unanimously in support of a J&J Covid-19 booster two months after one-dose shot

4 years ago

Incyte yanks EU application for PD-1 drug, citing inability to answer regulators' 'major concerns'

4 years ago

FDA's vaccine adcomm unanimously supports Moderna's booster in same populations as Pfizer's booster

4 years ago

Biden likely to nominate Verily's Rob Califf to lead the FDA again

4 years ago

Merck carves out path in first-line advanced cervical cancer with new FDA win for Keytruda juggernaut

4 years ago

Eli Lilly bags FDA nod for Verzenio in early breast cancer, but a controversial diagnostic could dog its rollout

4 years ago

First page Previous page 97 98 99100101 102 103 Next page Last page