Fda

US FDA vetoes Regeneron’s Eylea syringe in CRL

30-Oct-2018 By Flora Southey

The US FDA has rejected Regeneron Pharmaceuticals’ prior-approval supplement for Elyea pre-filled syringe, requesting additional clinical data and manufacturing information.

Infographic: Record year for ANDA approvals in US

26-Oct-2018 By Maggie Lynch

The US FDA reached a record number of generic ANDAs last financial year, ending September 2018.

Shire requests US approval to make Flexbumin at plasma plant

26-Oct-2018 By Flora Southey

Shire has filed a US FDA submission to manufacture plasma-volume replacement therapy, Flexbumin, at its new plant in Stanton Springs, Georgia.

Regeneron and Sanofi receives first US FDA approval for PD-1 treatment

03-Oct-2018 By Maggie Lynch

The US FDA approved the first drug created by the 2015 partnership between Regeneron and Sanofi to research and develop immuno-oncology therapies.

Lilly’s preventative migraine treatment receives US FDA green light

02-Oct-2018 By Maggie Lynch

Eli Lilly’s migraine treatment was approved by the US FDA, closely following a positive CHMP opinion, and will potentially be made available without cost for the first year.

Seqirus receives FDA approval on cell-based flu vaccine manufacturing process

11-Sep-2018 By Maggie Lynch

Seqirus received approval on its cell-based flu vaccine manufacturing process from the FDA, not long after its FY18 earnings showed profitability.

FDA approves treatment for rare type of lymphoma

29-Aug-2018 By Maggie Lynch

US Food and Drug Administration (FDA) has approved Poteligeo, a treatment for two rare non-Hodgkin lymphomas.

US FDA approves expanded label for Merck’s Keytruda as first-line treatment for NSCLC

22-Aug-2018 By Maggie Lynch

The US FDA has approved an expanded label for Merck’s Keytruda in combination with pemetrexed and platinum chemotherapy.

Regeneron sees rejection one day, US FDA approval the next

17-Aug-2018 By Flora Southey

The US FDA has approved Regeneron’s latest indication for eye drug Eylea, just four days after rejecting the sBLA in a complete response letter.

US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

15-Aug-2018 By Maggie Lynch

Genentech’s Xolair was granted a Breakthrough Therapy Designation by the US FDA.

Regulatory eyes on Regeneron: US FDA issues CRL for Eylea

14-Aug-2018 By Flora Southey

The US Food and Drug Administration has rejected Regeneron’s eye candidate, Eylea, but the biotech says it expects a final regulatory decision within two months.

Evolus boasts early resubmission of FDA-rejected Botox alternative

10-Aug-2018 By Flora Southey

Three months after the US FDA vetoed Evolus’ Botox alternative, the firm has announced its resubmission of DWP-450 for approval.

Samsung BioLogics approved to make first mAb for US market

27-Jul-2018 By Ben Hargreaves

Samsung BioLogics announced license-approval by the US FDA to create a mAb drug product at its Plant 1 facility.

US FDA puts gene-therapy on hold after DNA fragment found in plasmids

27-Jul-2018 By Maggie Lynch

Sarepta’s gene therapy clinical trial is put on hold by the US FDA after DNA fragment was found in plasmids during quality assurance testing.

Rubius to pay $8m for ex-Soliris plant with troubled past

27-Jul-2018 By Flora Southey

Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.