FDA+ channel feed – Endpoints News

FDA+ channel feed

Where are the interchangeable biosimilars?

6 years ago

FDA rebuffs little Assertio Therapeutics' long-acting ACTH formulation, shares sink

6 years ago

The FDA sets a regulatory speed record, providing a snap OK for Vertex's breakthrough triplet for cystic fibrosis

6 years ago

J&J's blockbuster Stelara wins US approval for ulcerative colitis

6 years ago

AstraZeneca's Farxiga scores FDA nod to cut risk of hospitalization for heart failure in diabetics

6 years ago

EMA backs seven therapies, including Merck's Ebola vaccine

6 years ago

As Osiris moves on from fraudulent past, one exec settles up with SEC

6 years ago

J&J's Xarelto, Amarin's Vascepa are cost-effective, not budget friendly — ICER

6 years ago

Another record year for generic drug approvals but questions on competition remain

6 years ago

Despite worries triggered by imbalance of deaths, Shionogi's antibiotic clears FDA panel vote

6 years ago

Patient experience data: Sanofi researchers call for more consistency from FDA

6 years ago

In reversal, NICE backs Rubraca after Clovis agrees to a price cut

6 years ago

Rare disease clinical trials: FDA awards $15M in grants

6 years ago

FDA approves drug for rare condition that triggers intense pain from light exposure

6 years ago

Is FDA too lax with its drug approval standards? Senior FDA officials discuss

6 years ago

Differin maker Galderma wins FDA approval for a new retinoid for acne

6 years ago

Gilead scores PrEP approval for Descovy — kicking off marketing push before Truvada generics swarm

6 years ago

In an unusual move, ICER rescinds draft report on JAK drugs for rheumatoid arthritis to revise its modeling approach

6 years ago

When can RWE translate into credible evidence? EMA officials discuss

6 years ago

Trump will pick Stephen Hahn as his next FDA commissioner — reports

6 years ago

Former FDA chief Califf is set to work full time for Alphabet

6 years ago

Patient-focused drug development: New FDA draft guidance delves into what’s important

6 years ago

J&J's embattled Invokana gets a boost as FDA expands label

6 years ago

FDA clears shorter treatment regimen for AbbVie's hep C treatment, Mavyret. Will patients benefit?

6 years ago

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