FDA approval Archives -

US House Energy & Commerce Committee Chair Frank Pallone (D-NJ) has introduced a new bill to enhance the

New bill moves to tighten accelerated approval regulation in US

https://pharmaphorum.com/news/new-bill-moves-to-tighten-accelerated-approval-regulation-in-us/

Boehringer Ingelheim, Biberach, Germany, February 2007

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

Eloise McLennan Boehringer Ingelheim, Eli Lilly, FDA approval, heart disease, pharma 0 Comment

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

https://pharmaphorum.com/news/fda-approves-jardiance-empagliflozin-for-wider-range-of-patients-with-heart-failure/

Market Access/ News/ News

Blueprint’s latest approval for Ayvakit sets up clash with Novartis

Phil Taylor Ayvakit, Blueprint Medicines, FDA approval, Novartis, Oncology, Rydapt, systemic mastocytosis 0 Comment

Blueprint Medicines has claimed its second FDA approval for Ayvakit, getting the nod for advanced systemic mastocytosis (SM),

Blueprint’s latest approval for Ayvakit sets up clash with Novartis

https://pharmaphorum.com/news/blueprints-latest-approval-for-ayvakit-sets-up-clash-with-novartis/

Market Access/ News/ News

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

Phil Taylor Alkermes, bipolar disorder, FDA approval, Lybalvi, Psychiatry, schizophrenia 0 Comment

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but

After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi

https://pharmaphorum.com/news/after-fda-approval-alkermes-plans-soft-launch-for-antipsychotic-lybalvi/

Market Access/ News/ News/ Top stories

FDA hands Cassiopea its first approval, for acne drug Winlevi

Phil Taylor Acne, Cassiopea, dermatology, FDA approval, Winlevi 0 Comment

Italian biotech Cassiopea has won US approval for Winlevi, a topical therapy it says is the first new

FDA hands Cassiopea its first approval, for acne drug Winlevi

https://pharmaphorum.com/news/fda-hands-cassiopea-its-first-approval-for-acne-drug-winlevi/

Market Access/ News/ News

ViiV gets FDA nod for Rukobia drug for older HIV patients

Phil Taylor antiviral, FDA approval, GlaxoSmithKline, HIV, infectious disease, ViiV Healthcare 0 Comment

The FDA has approved Rukobia, a first-in-class drug from ViiV Healthcare intended for older people with HIV, who

ViiV gets FDA nod for Rukobia drug for older HIV patients

https://pharmaphorum.com/news/viiv-gets-fda-nod-for-rukobia-drug-for-older-hiv-patients/

Market Access/ News/ News

AZ claims FDA okay for Brilinta in coronary artery disease patients

Phil Taylor AstraZeneca, Brilinta, cardiovascular, FDA approval 0 Comment

AstraZeneca’s anti-platelet drug Brilinta has been cleared in the US for a major new indication, preventing a first

AZ claims FDA okay for Brilinta in coronary artery disease patients

https://pharmaphorum.com/news/az-claims-fda-okay-for-brilinta-in-coronary-artery-disease-patients/

Market Access/ News/ News/ Top stories

BMS gets FDA nod for ozanimod, but launch will be delayed

Phil Taylor Bristol-Myers Squibb, FDA approval, multiple sclerosis, Ozanimod 0 Comment

Bristol-Myers Squibb’s multiple sclerosis therapy ozanimod has been approved by the FDA right on schedule, but the company

BMS gets FDA nod for ozanimod, but launch will be delayed

https://pharmaphorum.com/news/bms-gets-fda-nod-for-ozanimod-but-launch-will-be-delayed/

Market Access/ News/ News

Celgene scores FDA okay for thalassaemia drug Reblozyl

Phil Taylor Acceleron, anaemia, beta thalassaemia, Celgene, FDA approval 0 Comment

The FDA has approved Celgene and Acceleron’s Reblozyl, which is the first drug to be approved in the

Celgene scores FDA okay for thalassaemia drug Reblozyl

https://pharmaphorum.com/news/celgene-scores-fda-okay-for-thalassaemia-drug-reblozyl/

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