FDA Approval

The Food and Drug Administration (FDA) is banning the sale of menthol Vuse electronic cigarettes. The regulators also banned a fruit-flavored nicotine product from Vuse, and are considering whether to take action against the company's tobacco-flavored vapes as well.  Forbidden Fruit: Like...

On May 15th, mid-cap biotechnology company Sarepta Therapeutics was the big winner in an otherwise quiet day for the Russell 1000 Index. Sarepta jumped more than 30% after an FDA advisory panel narrowly recommended approval for the company's gene therapy for Duchenne Muscular Dystrophy (DMD)....

Virios Therapeutics Inc. (NASDAQ: VIRI) is a developmental-stage biotechnology company specializing in novel antiviral therapies for treating fibromyalgia and other abnormal immune response-triggered maladies. The company went public in December 2020. Shares reached a high of $16.71 before making...

Legend Biotech Corporation (NASDAQ: LEGN) is among the many healthcare names vying for a breakthrough in cancer treatment. Last week, the New Jersey-based company had just that. On April 19th, a data leak revealed that Legend Biotech's Carvykti, a blood cancer therapy, performed extremely well...

2022 would go down as one of the worst years for the financial markets. The sell-off has been all-pervasive, with stocks, bonds and cryptos all selling off indiscriminately. Even as high-fliers like Apple Inc. (NASDAQ: AAPL) and Tesla Inc. (NASDAQ: TSLA) bit the dust, there were a...

Biopharma stocks were not immune to the broader market downturn seen for much of 2022. The iShares Biotechnology ETF (NASDAQ: IBB), which is heavily weighted with large-cap biotech companies, has lost 13.2% compared to a steeper 27.8% pullback by the SPDR S&P Biotech (NYSE: XBI). What Happened...

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ: SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia. ROLVEDON (eflapegrastim-xnst) injection is a long-acting...

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ (NASDAQ: RVNC) lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severecfrown lines (glabellar lines) in adults. The regulatory approval was supported...

Soon after the European Commission's (EC) approval, Sanofi SA (NASDAQ: SNY) scooped up the FDA's OK for the first approved therapy to treat symptoms not related to the central nervous system in patients with acid sphingomyelinase deficiency (ASMD). The indication...

The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ: INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. The...

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ (NASDAQ: AXSM) lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. The AUVELITY New Drug Application (NDA) was...

The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ: BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. The...

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ: ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older. The regulatory approval is based on...

The U.S. Food and Drug Administration (FDA) has approved Horizon Therapeutics’ (NASDAQ: HZNP) supplemental Biologics License Application (sBLA) for expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, in patients with uncontrolled gout. The...

The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS). The regulatory...