FDA+ channel feed – Endpoints News

FDA+ channel feed

AstraZeneca, Merck win quick OK for a rare disease drug — as the FDA declares it can still move fast during a crippling pandemic

6 years ago

Covid-19 Tracker updates vaccine candidates

6 years ago

Hunting a full OK for Bavencio in frontline bladder cancer, Pfizer, Merck KGaA receive VIP treatment at FDA

6 years ago

Compounding drugs during the pandemic: FDA offers policy clarifications

6 years ago

FDA needs three more months to review Roche's SMA drug — giving Biogen, Novartis some relief

6 years ago

Acceleron's PAH drug gets the FDA's red carpet treatment with breakthrough status

6 years ago

Bristol Myers Squibb, Acceleron rack up second OK for Reblozyl, onto blockbuster status

6 years ago

Biotech execs warn that the FDA is fumbling their response to the Covid-19 open-door promise, delaying progress

6 years ago

FDA reports shortage of sedation drug used for putting Covid-19 patients on ventilators

6 years ago

FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns

6 years ago

FDA puts pediatric aGVHD drug on priority review lane — will they go virtual with the adcomm?

6 years ago

Have a new drug that promises to fight Covid-19? The FDA promises fast action but some developers aren't happy

6 years ago

Once furious over Novartis’ data manipulation scandal, the FDA now says it’s nothing they need to take action on

6 years ago

AstraZeneca gets a green light on Imfinzi for small-cell lung cancer — setting the stage for a battle with Roche's Tecentriq

6 years ago

FDA ends CSR pilot, plots new approach for disclosing study reports

6 years ago

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

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