FDA+ channel feed – Endpoints News

FDA+ channel feed

Pandemic travel restrictions force FDA to delay a BLA review — involving a site inspection in Korea

5 years ago

FDA gives AstraZeneca the thumbs-up to restart PhIII Covid-19 vaccine trials, and J&J is preparing to resume its study

5 years ago

In historic Covid-19 adcomm, vaccine experts debate a sea of questions — but offer no clear answers

5 years ago

FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism

5 years ago

On morning of FDA Covid-19 adcomm, Moderna completes PhIII enrollment, putting them neck-and-neck with Pfizer

5 years ago

Little Zosano takes another beating as the FDA slaps down their application for a migraine patch

5 years ago

As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

5 years ago

Oncology research mid-pandemic: Challenges may bring durable innovation

5 years ago

Cara lines up a $440M deal for US rights to its late-stage drug for severe itch, with $150M cash on the table

5 years ago

European regulators spurn Agios' AML drug Tibsovo, unconvinced by the same thin PhI data that won over the FDA

5 years ago

FDA officials, experts discuss impact of Covid-19 on cell and gene therapies

5 years ago

With all eyes on their Covid-19 drug, Regeneron wins a landmark approval in Ebola

5 years ago

Months after achieving unicorn status, Orca steers into the fast lane with an RMAT designation for cell therapy candidate

5 years ago

Vaxart was served a grand jury subpoena in July over its controversial role in OWS-funded preclinical study

5 years ago

Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH

5 years ago

Voyager shares take a hit as FDA slaps a hold on the IND for Huntington's gene therapy — their #2 play in the pipeline

5 years ago

Alkermes likely headed for approval after adcomm waves through schizophrenia and bipolar program

5 years ago

FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price

5 years ago

The ousted spokesperson that Stephen Hahn removed? FDA says she’s still an appointee, but won’t say what she does

5 years ago

In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder

5 years ago

FDA documents raise opioid abuse potential but pave a path toward badly-needed approval for Alkermes

5 years ago

Facing broad pushback from industry, White House backs down on FDA's Covid-19 vaccine guidance

5 years ago

No new guidance, but here's some advice: FDA draws a line in the sand for Covid-19 vaccine developers

5 years ago

Trump officials said industry didn't want FDA's stricter vaccine guidance, but the leading developer says they never discussed it

5 years ago

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