FDA

FDA Clears Clinical Trials on Investigational New Drug for ALS

by Veronica Salib

Amyotrophic lateral sclerosis, ALS, is a life-threatening neurodegenerative disease that can lead to paralysis and death. Over 5,000 individuals in the United States are diagnosed with ALS each year,...

FDA Recommends New Asthma Rescue Treatment

by Veronica Salib

AstraZeneca and Avillion recently teamed up to develop PT027, an asthma rescue inhaler. PT027 is a pressurized metered-dose inhaler that delivers a fixed dose of two combined asthma medications,...

Citeline and Norstella Merger Creates $5B Pharmaceutical Technology Company

by Hayden Schmidt

Norstella, a leading pharmaceutical solutions provider, completed its merger with Citeline earlier this month. As a result of the merger, Citeline will join Norstella’s group of brands, including...

A Single Dose of Psilocybin Can Reduce MADRS Score

by Veronica Salib

BMC Psychiatry states that up to one-third of patients with major depressive disorder become resistant to treatment, otherwise known as treatment-resistant depression. In recent years, psilocybin and...

FDA Approves Investigational Drug Application for Bi-Functional Fusion Protein

by Veronica Salib

In a recent announcement, the Simcere Pharmaceutical Group — a global pharmaceutical company with origins in China — revealed that the FDA approved its investigational new drug application...

Valisure Petitions FDA to Recall Dry Shampoos

by Veronica Salib

Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the propellant as the primary source. Since then, Valisure LLC, an independent...

RSV Cases Flood Children’s Hospitals as Pfizer Announces Promising Vaccine

by Hayden Schmidt

After producing strong clinical trial results for its respiratory syncytial virus (RSV) vaccine, Pfizer says it is ending enrollment in its study and preparing to submit for FDA approval. The Phase 3...

Understanding the FDA’s Expedited Approval Pathways

by Veronica Salib

The United States Food and Drug Administration (FDA) is responsible for regulating everything from cosmetic products to medical devices to prescription drugs. In recent years, the FDA has been under enormous pressure to accelerate its...

FDA Data Shows That 125 Drugs Are Currently in Short Supply

by Hayden Schmidt

On October 12, the FDA reported a shortage of amphetamine aspartate, more commonly known as Adderall. This was one of seven shortages reported by the FDA since the beginning of the month, and it joins...

FDA Awards 19 Grants for Rare Disease Research

by Veronica Salib

On October 17, 2022, the FDA announced that its Orphan Products Grants Program has awarded 19 grants and 2 contracts, amounting to over $38 million, for rare disease research. This action will...

Unilever Dry Shampoos Recalled Due to Carcinogens

by Veronica Salib

In an announcement published by the FDA on October 21, 2022, Unilever North America — a New Jersey-based cosmetics company — voluntarily recalled multiple dry shampoo aerosol products...

Etripamil Phase III Clinical Trials Are Successful

by Veronica Salib

Milestone Pharmaceuticals recently announced positive test results from a phase III clinical trial of etripamil, a calcium channel blocker to treat paroxysmal supraventricular tachycardia (PSVT). PSVT...

Understanding Differences between Generic, Brand Name, Biosimilars

by Veronica Salib

Every day patients, payers, and providers must navigate the pharmaceutical industry to obtain and deliver treatment. Unfortunately, the industry is full of language and nuances that make this process unnecessarily difficult. When providers...

COVID-19 Vaccination Alters Menstrual Cycle Length

by Veronica Salib

As the COVID-19 pandemic continues and vaccinations continue to be advanced, many patients are concerned about vaccine side effects. Multiple sources have perpetuated the misconception that COVID-19...

Biologics and Biosimilars Intelligence Consortium Awarded $1.3 Million

by Veronica Salib

On October 3, 2022, the FDA awarded the Biologics and Biosimilars Collective Intelligence (BBIC) a $1.3 million grant to be paid out in the next two years. The grant is intended to fund a study on...

FDA Approves Drug for Open-Angle Glaucoma and Ocular Hypertension

by Veronica Salib

In a recent press release, Santen announced that the FDA approved OMLONTI, the company’s newest ophthalmic medication. This ophthalmic solution is composed of 0.002% omidenepag isopropyl. This...

Patients, Providers, and the Public Hesitate to Adopt Digital Pills

by Veronica Salib

On November 13, 2017, Abilify MyCite became the first digital pill approved by the United States FDA. Since this approval and the initial surge of digital pills — sometimes called smart pills — the uptake and utilization have...

FDA Approves Relyvrio for ALS Treatment

by Veronica Salib

Yesterday, the FDA approved Relyvrio, an ALS drug developed by Amylyx Pharmaceuticals, after extensive discussions about the safety and efficacy of the drug. The drug was initially rejected by an FDA...

Pharmaceutical Company Biogen to Pay $900M False Claims Act Settlement

by Hayden Schmidt

Monday, Boston pharmaceutical company Biogen agreed to pay $900 million to settle a case where it was accused of offering illegal programs that induced physicians to prescribe the drugs Avonex,...

FDA Approved Psilocybin Investigational New Drug Application

by Veronica Salib

Psilocybin has become increasingly popular in pharmaceutical research to treat multiple neurological and mental health conditions. The FDA recently approved an investigational new drug (IND)...