FDA

T2 Biosystems Inc (NASDAQ: TTOO) announced Tuesday that it received FDA approval for a blood test to detect sepsis; the stock is down more than 11 percent in morning trading.  What Happened T2 Biosystems announced the FDA's market clearance for its T2Bacteria Panel. The panel...

Transenterix Inc (NYSE: TRXC) announced Tuesday that its laparoscopic Senhance Surgical System was approved by the FDA for two additional indications.  What Happened  The Senhance Surgical System received regulatory clearance for laparoscopic inguinal hernia and laparoscopic...

Biotech shares put up a lackadaisical show this week, as reflected by the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB). With earnings season winding down, FDA decisions and data presentations at conferences served as catalysts for stocks in the week. Here're are the key catalytic...

Novartis (NYSE: NVS) announced that its generic arm, Sandoz, obtained approval for Zessly, a biosimilar version of Johnson & Johnson (NYSE: JNJ)'s Remicade, in Europe. Zessly is approved for use in all indications of the branded drug including rheumatoid arthritis, adult Crohn's...

Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks Here are the biotech stocks that were hitting 52-week highs May 24:  ArQule, Inc. (NASDAQ: ARQL) Baxter International Inc (NYSE: BAX) BioLife Solutions Inc (NASDAQ: BLFS) Evolus Inc (...

Recro Pharma Inc (NASDAQ: REPH) needs an analgesic of its own. The firm announced Thursday morning that the U.S. Food and Drug Administration declined to approve its IV meloxicam application for non-opioid pain relief "in its current form." The Complete Response Letter acknowledged...

Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling the Peaks (Stocks hitting 52-week highs on May 23) ABIOMED, Inc. (NASDAQ: ABMD) ArQule, Inc. (NASDAQ: ARQL) Crispr Therapeutics AG (NASDAQ: CRSP) Evolus Inc (NASDAQ: EOLS)...

Shares of Cara Therapeutics Inc (NASDAQ: CARA) are surging to a three-month high in reaction to a licensing agreement the biotech company announced with Vifor Fresenius Medical Care Renal Pharma. What Happened Cara said it has licensed worldwide rights — except in the U.S., Japan and...

Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling the Peaks (Biotech Stocks Hitting 52-week highs on May 22) ArQule, Inc. (NASDAQ: ARQL) AstraZeneca plc (ADR) (NYSE: AZN) Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) Momenta...

Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling the Peaks (Biotech Stocks Hitting 52-week highs on May 21) AstraZeneca plc (ADR) (NYSE: AZN) (FDA approved its hyperkalaemia drug Lokelma) Atara Biotherapeutics Inc (NASDAQ: ATRA) Bio-Rad...

Below is a list of notable corporate events for the week beginning May 21. Note, this list is not comprehensive and all dates are subject to change. All times are ET. Monday Conferences UBS Global Healthcare Conference 2018 May 21-23 Notable Earnings Munro, Inc (NASDAQ: MNRO) Q4 premarket...

Barclays revised its view of several smaller mid-cap biotech stocks after the first-quarter earnings season, issuing re-ratings Monday for Prothena Corporation PLC (NASDAQ: PRTA) and Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN). The Analyst Barclays analyst Geoff Meacham downgraded Prothena...

Shares of Dova Pharmaceuticals Inc (NASDAQ: DOVA) trading was halted Monday morning in anticipation of a stock-sensitive announcement. What Happened The FDA announced its approval for Dova's New Drug Application for its lead product candidate Doptelet — chemically avatrombopag...

Some M&A activity, earnings news flow and clinical trial outcomes helped the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) preserve gains this week. As the earnings season winds down, here're are some upcoming week's key biotech events/catalysts that investors should stay...

The biotech analysts at Cantor Fitzgerald have a packed calendar: here are some of the dates they’re tracking and why they’re important. Mallinckrodt PLC (NYSE: MNK) is expected to release Phase 4 interim Acthar data for multiple sclerosis at the end of May, rheumatoid arthritis in...