ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.

FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

Intarcia Therapeutics’ GLP-1 agonist product candidate for type 2 diabetes now belongs to i2o Therapeutics, which will make the treatment’s case for approval at an upcoming FDA advisory committee meeting. The startup’s $46 million Series A financing is one of several recently announced funding rounds.

Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.

Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.

Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.

Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.

Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.

The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.

Biohaven’s bid to bring to market the first drug for rare neuromuscular disorder spinocerebellar ataxia has hit a setback. The FDA is refusing to review the drug’s application, a decision that could indicate the agency wants another clinical trial.

While Octapharma drug Balfaxar met the goal of its pivotal clinical trial, more deaths and blood clot problems were reported in the study drug arm versus the comparator group. The FDA is requiring a post-marketing study to further assess the drug’s risks.

Pear Therapeutics was once regarded as a digital therapeutics pioneer, but its spiral into bankruptcy has the industry searching for the best path forward. While some favor going direct to consumers, others say the solution is in generating more robust clinical trial data to persuade hesitant payers.

AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.

Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference.

FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.

Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.

A partial clinical trial hold has been lifted from cancer drug emavusertib and Curis has selected a dose to use in Phase 2 testing. The small molecule is being developed as a potential treatment for blood cancers.

Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.

CellTrans’s Lantidra is now the first FDA-approved cell therapy for type 1 diabetes. The therapy is made from islet cells sourced from deceased donors.

The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.

Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.

The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.

Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.

For the second time in three months, Mersana Therapeutics is dealing with an FDA clinical hold. The partial hold on tests of its experimental ovarian cancer drug follows a full hold placed on an early-stage test of a different Mersana therapy in various types of solid tumors.

he FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.