FDA+ channel feed – Endpoints News

FDA+ channel feed

EMA offers methodological considerations for trials during Covid-19 pandemic

6 years ago

Kept on hold at the FDA, Ipsen scraps a key trial and revamps R&D path for its troubled $1B-plus rare disease drug

6 years ago

Bristol Myers bags a long-awaited FDA OK for ozanimod — but the pandemic will keep it off the market

6 years ago

After critics lambasted Gilead for grabbing the FDA's special rare drug status on remdesivir, they're giving it back

6 years ago

FDA issues another safety alert related to fecal transplants, as data suggest coronavirus lingers in poop

6 years ago

BeiGene scrambles to find new Abraxane supplier as Chinese inspectors order halt on imports, citing Bristol Myers failure

6 years ago

The first big hurdle on the Celgene CVR arrives today. Can Bristol Myers clear a low bar in the middle of a pandemic?

6 years ago

BPCIA turns 10: Nearly 100 drugs become biologics

6 years ago

No surprise: After near unanimous adcomm, FDA rejects Eli Lilly bid to bring Jardiance to type 1 patients

6 years ago

J&J pitches its S1P1 MS drug into the regulatory ring as the competition heats up fast

6 years ago

FDA unveils guidance for Covid-19 trials

6 years ago

Contract manufacturer: FDA has halted domestic pharma inspections

6 years ago

FDA offers Roche an emergency OK for coronavirus testing tech — easing a critical logjam

6 years ago

Tainted donations from stool bank reignite safety concerns about poop transplants

6 years ago

A one-time biotech unicorn gets slaughtered as lead program is scrapped, highlighting lingering trouble

6 years ago

Coronavirus: WHO declares pandemic, EMA meetings go virtual

6 years ago

FDA drafts guidance on alternate electronic formats, announces support for new data standards

6 years ago

After hitting big in multiple myeloma, J&J, Genmab now have a new 'breakthrough' in NSCLC to boast about

6 years ago

Tiny Trevena returns to FDA in second bid for controversial opioid painkiller

6 years ago

FDA requires boxed warning for Singulair and its generics

6 years ago

Individualized therapies: CBER director discusses challenges, regulatory approach

6 years ago

Why FDA can’t disclose the first coronavirus-related drug shortage

6 years ago

Another hiccup for GW Pharma's seizure drug rival, as Zogenix discloses FDA review delay

6 years ago

FDA taps chemoradio-sensitizing head and neck cancer drug as 'breakthrough'

6 years ago

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