Topline The Food and Drug Administration on Friday approved a new nasal spray drug giant Pfizer says could offer “fast-acting relief” from migraines, launching a new form of medicine onto the market a...
Tag: FDA
What To Know About Mifepristone As Biden Administration Defends It From Legal Attack
Topline Vice President Kamala Harris spoke out Friday in defense of the abortion pill mifepristone as an ongoing lawsuit could soon bar it from distribution nationwide, potentially taking away million...
Moderna Stock Jumps On An FDA Boon For Its Cancer Vaccine
Moderna (MRNA) stock jumped late Wednesday after the Food and Drug Administration granted its Merck (MRK)-partnered cancer vaccine a breakthrough designation. X The companies are testing the personali...
Crispr Therapeutics: FDA Filing on Sickle Cell Gene Therapy Is Almost Done
An approval filing for a breakthrough treatment of sickle cell disease should be done by March, Crispr Therapeutics said, highlighting the company’s lead in a competitive area of medical research and ...
Growth Stock Boosted By FDA Approval For Multiple Sclerosis Treatment
Biotech growth stock TG Therapeutics (TGTX) got FDA approval for its multiple sclerosis drug in December, setting off a strong advance that’s added 80% so far this year. You can find these outst...
Opioid overdose treatment Narcan recommended by FDA advisors for over-the-counter use
The Food and Drug Administration’s independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly...
States says pulling FDA approval would be ‘devastating’
The attorneys general from 21 states and Washington, D.C., on Friday argued that the attempt to pull the abortion pill from the U.S. market would have “devastating consequences” for women....
FDA clearance of Covid shots and treatments won’t slow with end of public health emergency
Vials and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States logo. FDA finds the COVID-19 vaccine. Pavlo Gonchar | LightRocket | Getty Images The ...
Low Supplies Of Adderall And Prescription Startups Fueled Crisis
Topline Ritalin is the latest attention deficit hyperactivity disorder (ADHD) medication in short supply—after a months-long Adderall shortage—leaving patients who rely on these drugs to manage daily ...
FDA proposal would allow gay men in monogamous relationships to donate blood
A nurse fills test tubes with blood to be tested during an American Red Cross bloodmobile in Fullerton, CA on Thursday, January 20, 2022. Paul Bersebach | Medianews Group | Getty Images The Food and D...
FDA pulls Evusheld because it’s not effective against subvariants
Evusheld (tixagevimab and cilgavimab) injection, a new COVID-19 treatment that people can take before becoming symptomatic. (Chris Sweda/Chicago Tribune/Tribune News Service via Getty Images) Chris Sw...
FDA advisors recommend using Covid omicron shots for all doses
The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first ...
GenBioPro sues West Virginia, argues FDA preempts ban
Abortion pill manufacturer GenBioPro on Wednesday sued to overturn West Virginia’s ban on abortion because it restricts access to a medication approved by the Food and Drug Administration. The l...
FDA Lowers Recommended Levels of Lead In Baby Food: Here’s What That Means
Topline As part of their Closer to Zero program removing lead, arsenic, mercury and cadmium from children’s diets, the FDA released new guidelines Tuesday further limiting lead concentration in proces...
FDA proposes new lead limits for baby food
Jgi/jamie Grill | Tetra Images | Getty Images The Food and Drug Administration proposed new limits Tuesday on lead in baby food, in an effort to reduce exposure to a toxin that can impair childhood de...
FDA says most people probably need only one annual vaccine shot
Justin Sullivan | Getty Images The Food and Drug Administration has laid out a road map for what Covid-19 vaccination may look like moving forward. In a briefing document published Monday, the FDA sai...
Eat Just To Scale Up Cultured Meat Production On Gaining New Regulatory Approval In Singapore
Josh Tetrick (middle), cofounder and CEO of Eat Just Inc., has teamed up with family-owned Huber’s … [+] Butchery, a Singapore-based producer and suppliers of meat products, to sell their ...
CDC Exploring Possible But Unlikely Link Between Covid-19 Bivalent Booster And Strokes
Topline The Centers for Disease Control and Prevention and the Food and Drug Administration said Friday a possible link has been identified between Pfizer-BioNTech’s bivalent Covid-19 vaccine and isch...
Kala Pharmaceuticals stock up 750% in 3 days after upbeat FDA news on PCED treatment
Shares of Kala Pharmaceuticals Inc. KALA, +60.35% have rocketed higher in for three-straight sessions, toward a more-than 8-fold gain, since the biopharmaceutical company announced positive news regar...
Sesame To Become 9th Major Food Allergen On January 1, 2023
At the turn of the year, sesame will be officially joining milk, eggs, fish, Crustacean shellfish, … [+] tree nuts, peanuts, wheat, or soybeans as the ninth major food allergen. (Photo: Getty) g...
Now That FDA Approved TG Therapeutics Multiple Sclerosis Treatment, Analyst Are Boosting Price Targets
Wednesday, the FDA approved TG Therapeutics Inc’s (NASDAQ: TGTX) Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS). Briumvi is the first and only anti-CD20 monoclonal an...
AbbVie Holds Up in Ailing Market After FDA Approval; Top Funds Buy Shares
Boosted by another approval from the Food and Drug Administration (FDA), AbbVie (ABBV) has its sights set on a new buy point. And top money managers have their eyes on ABBV stock, which made the lates...
Kala Pharmaceuticals stock rockets nearly 300% after FDA OKs IND application for PCED treatment
Shares of Kala Pharmaceuticals Inc. KALA, +219.90% quadrupled in very volatile trading Wednesday, after the biopharmaceutical company said the Food and Drug Administration accepted its investigational...
FDA changes Plan B packaging to clarify that it is not an abortion pill
In this photo illustration, PlanB one-step emergency contraceptive is displayed on June 30, 2022 in San Anselmo, California. Justin Sullivan | Getty Images The Food and Drug Administration is changing...
State Lawmakers Seek To Stop Local Flavor Prohibitions
Ohio lawmakers passed a legislation to block locally-imposed prohibitions on flavored vape & tobacco … [+] products like the one enacted in Columbus. getty While the Biden White House contin...
FDA Commissioner urges parents not to stockpile children’s flu meds
The surge in flu cases and Covid-19 infections this month, along with elevated levels of childhood respiratory syncytial virus, or RSV infections, has caused elevated demand for children’s over-...
U.S., China Advance Discussions On Pact To Accelerate Cancer Drug Trials
U.S. Food and Drug Administration oncology chief Dr. Richard Pazdur. FDA U.S. and China health experts speaking at an online conference this month suggested that the two countries might be making prog...
2 Biotech Stocks Under $10 That Could Win From Key FDA Approvals
The biotech industry can bring investors some truly lucrative gains – but these stocks are not for the faint of heart. The companies bring to the table a combination of famously high overhead and long...
FDA to decide on Pfizer vaccine for older adults by May 2023
The Food and Drug Administration is expected to decide by spring whether to approve Pfizer’s vaccine to prevent respiratory syncytial virus, or RSV, in adults ages 60 and older. Pfizer, in a sta...
Elon Musk’s Neuralink Brain Implant Could Begin Human Trials In 2023
(Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images) SOPA Images/LightRocket via Getty Images Key takeaways Elon Musk’s Neuralink has applied to the FDA for approval to begin...