Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S.Food and Drug Administration (FDA) has approved KEYTRUDA®, the company’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Read More »

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).. Read More »

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 Read More »

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. Read More »

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.Food and Drug Administration (FDA) has approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 Read More »

Eli Lilly and Company (NYSE: LLY) today announced that the U.S Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. . Read More »

CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S.Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug Application (IND) for CTX001 for the treatment of sickle cell disease pending the resolution of certain questions that will be provided by the FDA as part of its review of the IND. Read More »

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S.Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. Read More »

The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). Read More »

.Pfizer Inc. (NYSE:PFE) announced today that tafamidis received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.1,2 Read More »

​Officially approved for leukemia treatment by the FDA just one month ago, Pfizer Inc.’s BESPONSA has gained a primary distributor to provide the drug to pharmacies across the U.S.  Read More »

The Rite Aid Foundation recently announced the rollout of its KidCents Safe Medication Disposal Program, which will focus on reducing drug accessibility, medication misuse and accidental poisoning of children and adolescents. Read More »

Novartis recently announced that the U.S. Food and Drug Administration (FDA) approved Kymriah suspension for intravenous infusion for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Read More »

Coherus BioSciences Inc. of Redwood City, California recently announced initial results from several current clinical pharmacokinetic bioequivalence (PK/BE) studies comparing two products, both developed for the purpose of addressing certain chronic arthritic and skin conditions. Read More »

Endo International plc of Dublin, Ireland recently launched shipping operations for its generic Sabril (vigabatrin for oral solution USP, 500 mg) product via Par Pharmaceutical, following final approval of its Abbreviated New Drug Application (ANDA). Read More »

Orfadin, a drug used to treat a condition causing kidney and liver damage, has now received the FDA’s go-ahead for once-a-day use, cutting its dosing frequency in half. Read More »

Accorda Therapeutics Inc. recently announced that the U.S. Food and Drug Administration (FDA) provided a Refusal to File (RTF) letter regarding the company’s New Drug Application (NDA) for Inbrija, an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Read More »

Novo Nordisk recently announced that the U.S. Food and Drug Administration approved a new indication for Victoza, which should help reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. Read More »

With the goal of treating dyskinesia in certain Parkinson’s disease patients, Adamas Pharmaceuticals of Emeryville, California recently obtained U.S. Food and Drug Administration approval for its Gocovri (amantadine) extended release capsules. Read More »