FDA+ channel feed – Endpoints News

FDA+ channel feed

China working on concessions to help homegrown companies stay on US exchanges — report

4 years ago

Pfizer pitches 4th Covid-19 vaccine shot for elderly despite mixed data from Israel

4 years ago

White House sounds the alarm on Covid-19 vaccine, monoclonal supply shortages

4 years ago

Genome editing products: FDA recommends at least 15 years of follow-up after clinical trials

4 years ago

FDA orders Incyte to hold up yet again in the hunt for blockbuster franchise

4 years ago

Moving up the treatment lines, AstraZeneca clinches adjuvant breast cancer OK for Lynparza

4 years ago

FDA hits back Fasenra in key rhinosinusitis field, putting AstraZeneca even further behind Big Pharma rivals

4 years ago

Senators call on CMS to finalize pharmacy fee reforms to save seniors $21B in out-of-pocket expenses

4 years ago

SEC singles out Zai Lab, BeiGene, Hutchmed for regulatory scrutiny — with threats of delisting

4 years ago

FDA lifts a clinical hold on Selecta gene therapy after another delay hampers R&D plans

4 years ago

Updated: Three big Congressional hearings next week to set the tenor on accelerated approvals, pandemics, drug prices, and ARPA-H

4 years ago

FDA's oncology adcomm to review PI3K inhibitors in blood cancers in April

4 years ago

Last-minute US spending bill features a beginning for ARPA-H, and half of what Biden requested for Covid-19

4 years ago

FDA resurrects proposal to gauge quality metrics in pharma manufacturing

4 years ago

Overhauling FDA's accelerated approval pathway: Key House committee chair pens new bill

4 years ago

Real world data and FDA: Drugmakers seek more clarity on registry guidance

4 years ago

A checkpoint 2.0 drug runs into trouble as Alpine gets hit with the latest in a string of clinical holds

4 years ago

FDA hands Bristol Myers a landmark approval in early-stage lung cancer after just five days

4 years ago

Aurinia faces choppy waters amid lower-than-expected 2022 guidance and patent challenge on Lupkynis

4 years ago

FDA pushes back a review date for TG's 'U2' combo as the biotech steels itself for upcoming adcomm

4 years ago

Two Republican senators call on CMS to not restrict coverage to amyloid-targeted Alzheimer's drugs

4 years ago

FDA begins court-mandated release of thousands of pages on Pfizer's Covid-19 vaccine review

4 years ago

As GSK is forced to slam the brakes, Pfizer cruises ahead with a ‘breakthrough’ on RSV

4 years ago

FDA slaps hold on Finch's microbiome C. difficile treatment, as biotech blames Covid-19 and old manufacturer

4 years ago

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