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FDA Approves Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry...

FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease

Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga)...

U.S. FDA Approves Subcutaneous Administration of Takeda's Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis

OSAKA, Japan and CAMBRIDGE, Massachusetts, September 27, 2023 – Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Approves Bosutinib for Pediatric Patients with Chronic Myelogenous Leukemia

On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic...

FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis

FARMINGTON HILLS, Mich., and PITTSBURGH, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical...

FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections

(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical...

Decrease in New Cancer Diagnoses Seen in 2020

There was a decrease in new cancer diagnoses in 2020, according to a report published online Sept. 27 in Cancer. Serban Negoita, M.D., Dr.P.H., from the...

Exposure to Job Loss in Pregnancy Linked to Miscarriage, Stillbirth

Exposure to job loss during pregnancy is associated with an increased risk for miscarriage and stillbirth, according to a study published online Sept....

Longer Nursing Shifts Tied to Higher Rates of Patient Incidents

Higher proportions of long nursing shifts are associated with higher rates of patient incidents (e.g., self-injury and disruptive behavior) in mental health...

FDA Panel Says No to Experimental ALS Drug

An advisory panel to the U.S. Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment...

Megan Thee Stallion Urges Fans to 'Check on Friends' for Mental Health

Megan Thee Stallion is urging you to check on your friends. The rapper, whose offstage name is Megan Pete, is part of a new public service announcement...

Biden Administration Gives Funding Boost to Help Curb Suicides

The Biden administration is allocating $232.2 million in grants to help stem suicides and improve behavioral health care for at-risk groups. Suicide is...

Oregon Decriminalized Possession of Small Amounts of Drugs. Fatal ODs Didn't Skyrocket

Critics of a law that decriminalized drug possession in Oregon have blamed the policy for rising overdose deaths in the state, but a new study finds no...

Health Issue Has Bruce Springsteen Postponing Shows for the Rest of the Year

Rock star Bruce Springsteen announced Wednesday that he has postponed all of his remaining shows this year as he deals with peptic ulcer disease. Springsteen...

BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the...

Scynexis Issues a Voluntary Nationwide Recall of Brexafemme (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

Scynexis, Inc. is conducting a voluntary nationwide recall of 2 lots of Brexafemme (ibrexafungerp tablets) to the consumer level in the US market due to...

IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer

IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces...

Your Wrist Could Give Clues to Future Health

One day, it may be possible to monitor people for risk of disease through continuously measuring skin temperature. Researchers have found in a new study...

FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label

Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s...

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer...

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Recently added consumer and prescribing information: Pombiliti, Likmez, Ojjaara, Tyruko, Bylvay, Xdemvy, Cyfendus, Ycanth, Beyfortus, Roctavian

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Latest FDA New Drug Approvals

  • Exxua Exxua (gepirone) is an azapirone antidepressant for the treatment of adults with major depressive disorder.
  • Pombiliti Pombiliti (cipaglucosidase alfa-atga) is a hydrolytic lysosomal glycogen-specific enzyme indicated in combination with Opfolda (miglustat)...
  • Ryzumvi Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis.

More FDA approvals

Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...
  • Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.

More drugs in development