Krystle Vermes

Ability Pharmaceuticals has received Orphan Drug Designation from the FDA for ABTL0812, its product designed to treat pancreatic cancer.

The FDA has approved Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA) in adults and children

Claris Injectables, a subsidiary of Claris Lifesciences, put its generic injectables unit up for sale last summer.

Baxter has entered a definitive agreement for the acquisition of India-based Claris Injectables for $625 million.

Abbreviated new drug application filed with the FDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).

The FDA granted orphan drug designation to nintedanib, a triple angiokinase inhibitor, for the treatment of mesothelioma.

Nintedanib combination shows significant clinical benefit treating mesothelioma

Boehringer Ingelheim has announced that the FDA has granted orphan drug designation to nintedanib, a triple angiokinase inhibitor, for the treatment of mesothelioma.

Officials with Elite Pharmaceuticals have filed an abbreviated new drug application with the FDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets) in doses of 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg.

Risankizumab achieved higher rates of clinical response in patients with Crohn’s disease.

Risankizumab is also being evaluated for the treatment of psoriasis, psoriatic arthritis, and asthma.

The FDA has granted orphan drug designation to AbbVie for risankizumab (ABBV-066) for the treatment of Crohn’s disease in pediatric patients.

The FDA has approved Synjardy XR (empagliflozin and metformin hydrochloride, extended-release) tablets for the treatment of type 2 diabetes in adults. In combination with diet and exercise, Synjardy XR can improve blood sugar in patients.

AcelRX has submitted a New Drug Application (NDA) to the FDA for ARX-04 (sufentanil tablets).

Biohaven, the biopharmaceutical company, has received orphan drug designation from the FDA for BHV-0223, its drug candidate designed to treat amyotrophic lateral sclerosis (ALS).

Clobetasol propionate lotion can be used for the treatment of moderate-to-severe plaque psoriasis.

Armodafinil is designed to improve wakefulness in adult patients with excessive sleepiness due to obstructive sleep apnea, narcolepsy, or shift work disorder.

The FDA has green-lighted the Abbreviated New Drug Application (ANDA) for armodafinil tablets.

Egalet has submitted a supplemental new drug application (sNDA) to the FDA for Oxaydo, (oxycodone HCl, USP) in favor of an abuse-deterrent label claim for the intravenous route of abuse.

Abilify treats symptoms of psychotic conditions, such as schizophrenia, in a wide range of patients.

Ajanta has launched aripiprazole tablets in 2.5-mg, 5-mg, 10-mg, 15-mg, 20-mg, and 30-mg doses in the United States.

The FDA has granted PhaseRx Inc. orphan drug designation for PRX-OTC, an intracellular enzyme replacement therapy that can potentially treat ornithine transcarbamylase deficiency (OTCD) in children.

The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted 7-6 that the efficacy results of Cempra's solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia (CABP).

Following reports of pain and other adverse events, Essure, the permanently implanted birth control device for women from Bayer, now includes a new boxed warning and a Patient Decision Checklist.

Voriconazole tablets available in 50-mg and 200-mg doses in the US market.

Ajanta has launched voriconazole tablets in 50-mg and 200-mg doses in the US market. These tablets are the equivalent generic version of Vfend, an antifungal drug from Pfizer.

Allergan has launched Taytulla, an estrogen/progestin combination oral contraceptive, in a 1-mg/20-mg capsule form.

Collaboration will examine potential opportunities for combining daratumumab and carfilzomib for the treatment of cancer.

Janssen has entered a clinical trial collaboration and supply agreement with Onyx to evaluate the efficacy and safety of Darzalex, the first-in-class CD38-directed immunotherapy daratumumab, in combination with a proteasome inhibitor carfilzomib and dexamethasone.