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FDA/Panel Decisions

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Swiss drug maker Roche Group (RHHBY) announced Wednesday that the US Food and Drug Administration approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane and carboplatin) for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer or NSCLC with no...

Pharmaceutical company Mylan N.V. (MYL) and India-based Biocon Ltd. announced Monday the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). The product is co-developed by Mylan and Biocon. Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug...

AstraZeneca plc (AZN.L, AZN) announced the US FDA has accepted a supplemental Biologics License Application and granted Priority Review for Imfinzi for the treatment of patients with previously untreated extensive-stage small cell lung cancer. The sBLA was based on positive results from the Phase III...

earinfections-nov26.jpg The U.S. Food and Drug Administration approved a new system for the delivery of ear tubes into the eardrum under local anesthesia and minimal discomfort to the patient to treat recurrent ear infections. The regulator granted approval for Tusker Medical's Tubes Under Local Anesthesia System as the first ear tube delivery system that can be performed using local anesthesia.

Shares of Aquestive Therapeutics, Inc. (AQST) are up 21.15% in pre-market trading on Monday, following FDA approval of its drug Exservan for the treatment of neurological disorder amyotrophic lateral sclerosis (ALS).

Genentech, a member of the Roche Group (RHHBY.PK), announced the U.S. FDA has accepted the New Drug Application and granted priority review for risdiplam, an investigational survival motor neuron-2 splicing modifier for spinal muscular atrophy. Previously, the FDA granted Orphan Drug Designation for...

myopia-nov18.jpg The U.S. Food and Drug Administration approved the first contact lens developed for slowing the progression of myopia or nearsightedness in children between the ages 8 and 12 years at the initiation of treatment. This could also help in ultimately reducing risk of developing other eye problems. The regulator granted approval for CooperVision Inc.'s MiSight contact lens.

Pfizer Inc.'s ( PFE) ABRILADA, a biosimilar to Humira, has received FDA approval for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Pfizer Inc. (PFE) announced the FDA has approved ABRILADA as a biosimilar to Humira for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. ABRILADA...

dollartree-nov15.jpg Greenbrier International, Inc., doing business as Dollar Tree, received a warning letter from the U.S. Food and Drug Administration for receiving potentially unsafe drugs. In a statement, the FDA noted that Dollar Tree, which operates a chain of supermarkets, received over-the-counter or OTC drugs made by foreign manufacturers in violation of federal law.

The FDA has turned down Lipocine Inc.'s (LPCN) TLANDO, an oral testosterone product candidate for testosterone replacement therapy in adult males for hypogonadism, yet again.

Lipocine Inc. (LPCN) has received a Complete Response Letter or CRL from the FDA regarding the company's New Drug Application for TLANDO, an oral testosterone product candidate. The FDA has stated that the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations. "We...

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