July 26th 2024
Adults with severe alopecia were shown to have statistically significant efficacy across 2 phase 3 clinical studies highlighted in this announcement.
July 25th 2024
The expanded label includes use in patients with PFIC 12 months of age and older as well as a higher concentration formulation.
July 22nd 2024
Johnson & Johnson submits a supplemental New Drug Application to the FDA for the approval of esketamine as a monotherapy for adults with treatment-resistant depression.
The approval was based on the clinical, non-clinical, and analytical data proving eculizumab-aagh's bioequivalence to the reference drug.
July 18th 2024
Announced on July 18, 2024, the FDA approval for heartburn relief associated with non-erosive GERD is based on the phase 3 PHALCON-NERD-301 trial.
FDA Issues Complete Response Letter for Once-Weekly Insulin Icodec
The CRL cites requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.
Roflumilast Cream Receives FDA Approval for Atopic Dermatitis
This decision by FDA officials resulted from the INTEGUMENT study findings which determined that once-daily roflumilast led to rapid eczema clearance and significant disease reductions.
7 FDA Drug Decisions Anticipated Before the End of 2024
After a busy first half to 2024, a number of high-impact FDA decisions await the healthcare industry through December.
FDA Approves Prefilled Syringe of Faricimab (Vabysmo) for AMD, DME, and RVO
Announced by Genentech on July 04, 2024, the prefilled, 6.0 mg syringe is designed to improve ease of administration and offer ophthalmologists with a ready-to-use version of the bispecific antibody.
Cardiology Month in Review: June 2024
Our Cardiology Month in Review for June 2024 spotlights the pharmacotherapies making waves within the pipeline, the latest news in dyslipidemia, and updates in heart failure.
FDA Accepts NDAs for Crinecerfont in Congenital Adrenal Hyperplasia
Neurocrine Biosciences was granted Priority Review designations for two crinecerfont NDAs focused on children, adolescents, and adults with classic CAH.
FDA News Recap: Novel Drug Approvals in First Half of 2024
A review of the 20 novel drugs approved by the US Food and Drug Administration during the first half of 2024, with links to coverage from MJH Life Sciences publications.
Mirum Pharmaceuticals Submits NDA for Chenodiol Tablets in Cerebrotendinous Xanthomatosis
Mirum Pharmaceuticals submitted an NDA for chenodiol tablets to treat CTX based on positive phase 3 RESTORE trial results.
FDA Grants Marketing Authorization to Xpert HCV, First Point-of-Care Hepatitis C RNA Test
The marketing authorization makes the Xpert HCV test and GeneXpert Xpress System the first point-of-care test for diagnosing HCV.
FDA Approves Ensifentrine (Ohtuvayre) for COPD
Ensifentrine, a PDE3 and 4 inhibitor from Verona Pharma, was associated with significantly improved lung function and reduced COPD exacerbations over 24 weeks.
FDA Grants Priority Review for Olezarsen in Familial Chylomicronemia Syndrome
The FDA accepted the NDA for olezarsen, an RNA-targeted medicine, in familial chylomicronemia syndrome for priority review, with a PDUFA date set for December 19, 2024.
FDA Accepts sNDA for Brexpiprazole in Combination with Sertraline for Adult PTSD
FDA accepts a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, with a PDUFA date of February 8, 2025.
FDA-Approved Red-Light LED Lamp Released for Patients with Actinic Keratosis
The announcement follows the release of the RhodoLED XL red light-emitting lamp, to be used in combination with aminolevulinic acid hydrochloride topical gel, 10% for actinic keratoses
FDA Approves Pitolisant for Excessive Daytime Sleepiness in Pediatric Patients
FDA approves pitolisant for excessive daytime sleepiness and cataplexy in pediatric patients aged ≥ 6 years with narcolepsy.
FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis
The approval is based on data from a pair of phase 3 studies and makes risankizumab-rzaa the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn’s disease.
FDA Clears Wireless Electrocardiogram Device for Collecting Spirometry, ECG Data
The FDA provided 510(k) clearance for the COR-12 wireless ECG device, which was now integrated with the SpiroSphere.
FDA Approval of Single-Dose Tralokinumab Autoinjector for Adults with Atopic Dermatitis
This approval by FDA officials allows patients an alternative option to pre-filled syringe, which had been the only choice for those with eczema prescribed tralokinumab.
FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC
The accelerated approval is based on data from the phase 3 ELATIVE trial demonstrating a reduction in alkaline phosphatase with elafibranor.
FDA Approves Tirbanibulin for Actinic Keratosis on Larger Areas of Face, Scalp
The new approval expands the treatment area by 4 times the previously approved area—from 25 cm2 to 100 cm2.
FDA Awards Breakthrough Device Designation to AI Platform for Classifying Skin Cancer
The VIO Skin Platform by Enspectra Health was designed to assess lesions indicating either basal cell carcinoma or squamous cell carcinoma.
FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD
Follow HCPLive's coverage of the full-day FDA committee meeting regarding Lykos Therapeutics' application for MDMA-assisted therapy as a novel treatment for patients with PTSD.
Upadacitinib Expands Indication to Pediatric Patients with pJIA, PsA
The approvals were based on data from well-controlled studies of the drug in adult patients with PsA and RA.
Amy Emerson: The FDA Advisory Committee Meeting for Lykos' MDMA-Assisted Therapy
Emerson previews the highly anticipated FDA advisory committee this week, and Lykos' plans for rolling out MDMA-assisted therapy in the event it is approved to treat PTSD.
FDA Extends Dupilumab COPD Decision to September 2024
The FDA moved the target date for their decision on the dupilumab application by 3 months, citing a need for more efficacy data from its pivotal phase 3 trials.
FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS
The FDA approved eculizumab-aeeb (Bkemv) as an interchangeable biosimilar to eculizumab (Soliris) for treating PNH and aHUS, marking the agency’s 53rd biosimilar approval.
FDA Grants Breakthrough Device Designation to Blood Test Measuring Lp(a)
Announced on May 22, 2024, the Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream to evaluate cardiovascular risk.
FDA Approves First Interchangeable Biosimilars to Eylea
On May 20, 2024, the FDA announced the approval of 2 products as interchangeable biosimilars to aflibercept—the first products to receive such a designation from the FDA.
FDA Clears IND Application for CID-103 in Immune Thrombocytopenia
Announced on May 15, 2024, the IND application supports a phase 1/2 study of CID among adults with chronic ITP.
FDA Extends Review for TransCon PTH in Hypoparathyroidism to August 2024
The FDA has extended the review period for palopegteriparatide in treatment of hyperparathyroidism in adult patients by 3 months to August 14, 2024.
FDA Issues CRL for HEPLISAV-B in Adults on Hemodialysis
The CRL for the sBLA cites a lack of sufficient data to support the full evaluation of the effectiveness and safety of a 4-dose regimen in this patient population.