FDA/Panel Decisions

AbbVie (ABBV) announced the FDA has approved SKYRIZI as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn's disease. The company said the third approved indication for SKYRIZI is supported by safety and efficacy data from two induction...

Advisers to the U.S. Food and Drug Administration recommended authorizing Pfizer/BioNTech and Moderna Covid-19 vaccines for children as young as 6 months, reports said. All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of the decision for both companies' vaccines, stating that the benefits outweigh their risks.

The U.S. Food and Drug Administration advisers recommended to authorize Moderna's two-dose COVID-19 vaccine for children and teens aged 6 to 17 years, reports said. The FDA is expected to authorize the Moderna vaccine for ages 6-17 soon as the agency generally follows the recommendations of its advisers, even though it is not obliged to do so.

Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Tuesday its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth...

The FDA has approved Eli Lilly and Co. (LLY) and Incyte Corp.'s (INCY) Olumiant for yet another indication, this time, for the treatment of adult patients with severe alopecia areata.

Oxford Biomedica plc (OXB.L), a gene and cell therapy group, Tuesday noted that the U.S. Food and Drug Administration has lifted clinical hold on Homology Medicines Inc.'s pheNIX gene therapy trial. Homology Medicines, a genetic medicines company, is the owner of 20 percent stake in Oxford Biomedica...

The U.S. Food and Drug Administration approved Eli Lilly and Co.'s Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness. This is the first FDA approval of a systemic treatment, i.e. treats the entire body rather than a specific location, for alopecia areata.

Inhibikase Therapeutics, Inc. (IKT) said the company is advancing phase 2a study of IkT-148009 in untreated Parkinson's patients following review of the study protocol and phase 1/1b data by the FDA. Inhibikase stated that following a review of IkT-148009 safety, tolerability and PK data in the first...

LENSAR, Inc. (LNSR), a commercial-stage medical device company, announced FDA 510(k) clearance for next-generation ALLY Adaptive Cataract Treatment System. ALLY is the first FDA-cleared platform to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery procedure in a single,...

COVID-19 vaccine by Pfizer and its German partner, BioNTech, was effective and safe for use in children aged 6 months to 4 years, reports said citing the U.S. Food and Drug Administration staff reviewers. FDA staff stated that the available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 yea

Pharmaceutical company Amarin Corp. plc (AMRN) announced Friday that the UK's National Institute for Health and Care Excellence (NICE) is recommending icosapent ethyl (VAZKEPA) for reimbursement and use across the National Health Service (NHS) in England and Wales. It is indicated to reduce the risk...

Genetic medicines company Passage Bio, Inc. (PASG) announced Wednesday that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PBML04, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for the treatment of Metachromatic...

Swiss drug major Roche Holding AG (RHHBY) announced Wednesday that the European Commission has granted conditional marketing authorisation for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab). The approval is for the treatment of adult patients with relapsed or refractory...

Amylyx Pharmaceuticals, Inc. (AMLX) announced the FDA has extended the review timeline of the New Drug Application for AMX0035 for the treatment of amyotrophic lateral sclerosis. The updated PDUFA goal date is September 29, 2022. The FDA extended the PDUFA date to allow more time to review additional...