#fda-approval

#fda-approval

Medicare may cover anti-obesity drug Wegovy for cardiovascular risks

Drug companies seek FDA approval for weight-loss drugs for various other conditions [ more ]

MDMA's potential for PTSD treatment faces uncertainty in FDA approval. [ more ]

The US Drug Enforcement Administration is poised to reclassify marijuana to a lower-risk drug category, aligning with health department recommendations and acknowledging potential medical benefits. [ more ]

Pivmecillinam, a new antibiotic approved by the FDA for UTIs, offers a crucial solution for the increasing resistance to existing antimicrobial drugs. [ more ]

CAR-T therapy is successful in some blood cancers but not yet approved for solid tumors. Tumor-Infiltrating Lymphocytes (TIL) use immune cells from a patient's tumor for treatment. [ more ]

Neuralink's N1 device enables patients to carry out actions through concentration alone.

The N1 implant combines advanced technologies and has received approval from the FDA for human trials. [ more ]

The FDA approved a new treatment, tarlatamab, for small cell lung cancer patients with limited life expectancy, showing potential with tripled life expectancy and practice-changing impact. [ more ]

Zepbound, a weight loss drug, shows potential in treating obstructive sleep apnea, with trial results prompting Eli Lilly to seek FDA approval for expanded use. [ more ]

Frostbite treatment historically included rewarming, aspirin, amputation, and waiting for auto-amputation.

FDA approved iloprost as the first therapy for severe frostbite, improving blood circulation and limiting tissue damage. [ more ]

Samsung receives FDA approval for sleep apnea feature in Samsung Health Monitor app

Sleep apnea feature will detect signs of moderate to severe obstructive sleep apnea over a two-night monitoring period [ more ]

New drug Zevtera approved by FDA to treat certain staph infections.

Elected officials aim to address the issue of squatters invading and vandalizing buildings. [ more ]

Pulmonary arterial hypertension (PAH) is a rare form of hypertension affecting lung arteries, leading to heart problems.

FDA approved a new Merck drug, Winrevair (sotatercept), which targets an underlying cause of PAH and helps alleviate symptoms. [ more ]

Gene therapy approved for rare disease dramatically improves quality of life for children.

High price of the therapy raises concerns about affordability and access. [ more ]

Blood test for colon cancer showed 83% accuracy in detecting cancers.

Colonoscopies remain the gold standard for colon cancer screening, detecting both tumors and precancerous growths. [ more ]

Blood test can detect 83% of colorectal cancer cases

FDA approval could offer a less invasive screening option [ more ]

Lecanemab approved by FDA for Alzheimer's treatment

Disease-modifying drugs target root cause and offer cumulative benefits [ more ]

Wegovy lowers cardiovascular risks in obese individuals with heart disease by 20%

Obesity drug Wegovy is a significant advancement in weight loss medication [ more ]

FDA approved first prescription-free CGM

Stelo designed for non-insulin users to monitor glucose levels [ more ]

Opill is the first birth control pill available over the counter in the U.S.

Opill is a progestin-only pill, meaning no estrogen in it. [ more ]

Asthma drug omalizumab shown to protect against severe food allergic reactions.

67% of those who received omalizumab could ingest small amounts of peanuts without reaction, compared to 7% with a placebo. [ more ]

Two studies retracted due to methodology issues and conflicts of interest, contrasting with previous research supporting mifepristone safety.

Abortion pill mifepristone, used in combination with misoprostol, is FDA-approved for early-stage abortions and is safe and effective. [ more ]

Xolair medication helps prevent severe food allergy reactions.

Xolair is approved by the FDA for preventing anaphylactic shock in patients with food allergies. [ more ]

Xolair is a newly approved drug by the FDA to help protect against severe allergic reactions related to multiple food allergies

Xolair needs to be taken repeatedly every few weeks to reduce the risk of reactions over time. [ more ]

Amtagvi is the first cell therapy for solid tumors approved by the FDA

It is designed to treat aggressive forms of melanoma that cannot be removed with surgery or have spread to other parts of the body [ more ]

For-profit ketamine clinics have grown in popularity and offer infusions for various mental health issues.

Ketamine is not approved by the FDA for mental health treatment, leading to wide variability in treatment protocols among providers. [ more ]

Antiviral drugs that treat mild-to-moderate cases of COVID-19 are available overseas but not yet approved for use in the U.S.

A study showed that simnotrelvir, an antiviral drug available in China, shortened the recovery time for young, vaccinated individuals with COVID-19. [ more ]

The Food and Drug Administration has approved the first gene editing therapy and conventional gene therapy for sickle cell disease.

Obstacles to treatment include limited access to authorized medical centers, individualized procedures, and high costs. [ more ]