regulatory approval Archives -

The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved

BioMarin gene therapy for haemophilia on course for EU approval

https://pharmaphorum.com/news/biomarin-gene-therapy-for-haemophilia-on-course-for-eu-approval/

News/ News/ Sales and Marketing

AbbVie’s Skyrizi beats IL-23 rivals to Crohn’s disease approval

Phil Taylor AbbVie, Crohn's disease, inflammatory bowel disease, regulatory approval, Skyrizi 0 Comment

AbbVie’s IL-23 inhibitor Skyrizi trailed some of its rivals in its first indication psoriasis, but has leapfrogged into

AbbVie’s Skyrizi beats IL-23 rivals to Crohn’s disease approval

https://pharmaphorum.com/news/abbvies-skyrizi-beats-il-23-rivals-to-crohns-disease-approval/

Market Access/ News/ News/ News/ Sales and Marketing

Alnylam grabs FDA approval for its second amyloidosis therapy

Phil Taylor Alnylam Pharmaceuticals, Amvuttra, ATTR amyloidosis, Ionis Pharmaceuticals, Onpattro, regulatory approval, SOBI, Tegsedi 0 Comment

Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis,

Alnylam grabs FDA approval for its second amyloidosis therapy

https://pharmaphorum.com/news/alnylam-grabs-fda-approval-for-its-second-amyloidosis-therapy/

Market Access/ News/ News

Amylyx bags first approval for ALS drug Albrioza

Phil Taylor Albrioza, Amylyx, amyotrophic lateral sclerosis, Canada, Mitsubishi Tanabe, neurology, Radicava, regulatory approval 0 Comment

Amylyx Pharmaceuticals’ efforts to bring its amyotrophic lateral sclerosis therapy AMX0035 to market in the US have run

Amylyx bags first approval for ALS drug Albrioza

https://pharmaphorum.com/news/amylyx-bags-first-approval-for-als-drug-albrioza/

News/ News/ Oncology

Roche’s Tecentriq extends lead over Keytruda in adjuvant NSCLC

Phil Taylor adjuvant, immuno-oncology, Keytruda, Merck & Co, Non-small cell lung cancer, Oncology, regulatory approval, Roche, Tecentriq 0 Comment

While Merck & Co’s Keytruda is the undisputed leader of the non-small cell lung cancer (NSCLC) category, there’s

Roche’s Tecentriq extends lead over Keytruda in adjuvant NSCLC

https://pharmaphorum.com/news/roches-tecentriq-extends-lead-over-keytruda-in-adjuvant-nsclc/

Market Access/ News/ News/ News/ Oncology

EU first to clear Roche’s lymphoma bispecific mosunetuzumab

Phil Taylor follicular lymphoma, immuno-oncology, Lunsumio, mosunetuzumab, non-Hodgkin lymphoma, Oncology, regulatory approval, Roche 0 Comment

Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for

EU first to clear Roche’s lymphoma bispecific mosunetuzumab

https://pharmaphorum.com/news/eu-first-to-clear-roches-lymphoma-bispecific-mosunetuzumab/

Market Access/ News/ News/ News/ Sales and Marketing

Roche puts pressure on SMA rivals with new FDA approval

Phil Taylor Biogen, Evrysdi, Novartis, PTC Therapeutics, regulatory approval, Roche, SMA, Spinraza, Zolgensma 0 Comment

Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger

Roche puts pressure on SMA rivals with new FDA approval

https://pharmaphorum.com/news/roche-puts-pressure-on-sma-rivals-with-new-fda-approval/

News/ News/ Oncology

BMS’ Opdivo gets late-stage oesophageal cancer nod from FDA

Phil Taylor Bristol-Myers Squibb, immuno-oncology, Keytruda, Merck & Co, oesophageal cancer, Oncology, Opdivo, regulatory approval 0 Comment

The FDA has cleared two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously-untreated advanced

BMS’ Opdivo gets late-stage oesophageal cancer nod from FDA

https://pharmaphorum.com/news/bms-opdivo-gets-late-stage-oesophageal-cancer-nod-from-fda/

News/ News/ Oncology

J&J, Legend get EU nod for myeloma CAR-T Carvykti

Phil Taylor CAR-T therapies, Carvykti, EU, immuno-oncology, Johnson & Johnson, multiple myeloma, Oncology, regulatory approval 0 Comment

Johnson & Johnson and Legend Biotech will arrive at next week’s ASCO congress with a new EU approval

J&J, Legend get EU nod for myeloma CAR-T Carvykti

https://pharmaphorum.com/news/jj-legend-get-eu-nod-for-myeloma-car-t-carvykti/

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