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Category: Regulations


FDA, Regulations

FDA panel shoots down Spectrum, Oncopeptides’ cancer drugs

September 23, 2022

Via: Pharmaphorum

It was already unlikely that the two companies would get a positive outcome from the Oncologic Drugs Advisory Committee (ODAC), after damning assessments by the FDA reviewer in documents published ahead of yesterday’s decisions, but shares in both firms still […]


FDA, Regulations

FDA Approves Bluebird Bio’s $3 Million CALD Treatment

September 21, 2022

Via: Biopharm International

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD. FDA announced that it had granted approval of SKYSONA (elivaldogene automecel) to bluebird bio for the treatment of […]


FDA, Mergers and Acquisitions, Regulations

FDA and NIH Enter Rare Neurodegenerative Diseases Partnership

September 21, 2022

Via: Biopharm International

FDA and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a public-private partnership, on Sept. 14, 2022. The goal of this partnership is to advance the understanding and develop treatments […]


FDA, Regulations

FDA Warns Against Overuse of TPOXX Monkeypox Drug

September 16, 2022

Via: Drugs.com

U.S. health officials are advising doctors not to overuse the only antiviral for monkeypox because there is a risk of the virus mutating and rendering the drug useless. TPOXX (tecovirimat) works by targeting just one protein found on monkeypox, as […]


FDA, Regulations

FDA starts review of first drug for alpha-mannosidosis, from Chiesi

September 13, 2022

Via: Pharmaphorum

The vanishingly rare, progressive, and debilitating disease is caused by a deficiency in the enzyme alpha-mannosidase, leading to a build-up of complex sugars that damage the central nervous system and organs of the body. Patients with alpha-mannosidosis are typically diagnosed […]


FDA, Regulations

Dogs Have Died After Licking a Common Chemotherapy Cream, FDA Warns

September 9, 2022

Via: Drugs.com

Your dog may like to lick your hand or face, but if you’re using a chemotherapy cream that treats certain skin conditions, you should not allow it, the U.S. Food and Drug Administration advises. The medication fluorouracil is fatal to […]


FDA, Regulations

FDA Approves Botox Competitor That Lasts Longer

September 9, 2022

Via: Drugs.com

People wanting to keep wrinkles at bay will soon have a new option now that the U.S. Food and Drug Administration has approved the first competitor for Botox in decades. Daxxify, made by Revance Therapeutics Inc. in Nashville, Tenn., is […]


FDA, Regulations

FDA grants Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus vaccine candidate

September 7, 2022

Via: World Pharma News

Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine […]


FDA, Regulations

FDA Panel Skeptical of Controversial ALS Drug Ahead of Vote

September 6, 2022

Via: Drugs.com

U.S. Food and Drug Administration panel will once again consider approval for an experimental drug for ALS, a rare second review for a disease that has no cure. The same panel that will meet Wednesday voted last March not to […]


FDA, Regulations

FDA gives AZ the nod for Imfinzi in biliary tract cancer

September 5, 2022

Via: Pharmaphorum

Imfinzi (durvalumab) has been cleared by the US regulator for the treatment of adult patients with locally advanced or metastatic BTC in combination with gemcitabine/cisplatin chemotherapy, extending the use of Imfinzi beyond lung cancer for the first time. The approval […]


FDA, Regulations

Sanofi, after long research journey, wins FDA approval for rare disease drug

September 1, 2022

Via: Biopharma Dive

The approval comes after more than two decades of research and development by rare disease specialist Genzyme, which Sanofi bought in 2011 for $20.1 billion. Patients with ASMD suffer from a lack of an enzyme needed to break down a […]


FDA, Regulations

FDA Warns of Dangers From Skin Lightening Creams

September 1, 2022

Via: Drugs.com

Skin lightening products can be dangerous for consumers when they contain harmful ingredients that are illegal for over-the-counter sales, the U.S. Food and Drug Administration warned Wednesday. The potentially harmful ingredients are hydroquinone or mercury, the agency said in a […]


FDA, Regulations

FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease

August 31, 2022

Via: World Pharma News

Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Xenpozyme is the first approved medication to treat […]


FDA, Regulations

FDA Authorizes Pfizer, BioNTech Omicron Adapted COVID-19 Vax Booster

August 31, 2022

Via: Contract Pharma

Pfizer Inc. and BioNTech SE was granted Emergency Use Authorization (EUA) by the U.S. FDA for a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and […]


FDA, Regulations

FDA clears bivalent Omicron shots from Pfizer, Moderna

August 31, 2022

Via: Pharmaphorum

The US regulator has cleared a 30 µg booster dose of a new version of Pfizer’s Comirnaty shot – 15 µg encoding the spike protein of the original wild-type SARS-CoV-2 strain and 15-µg of mRNA coding for Omicron BA.4/BA.5 – […]


FDA, Regulations

Thousands of U.S. Patients Got COVID Treatments Rejected as Useless by FDA

August 29, 2022

Via: Drugs.com

U.S. doctors administered more than 150,000 doses of useless monoclonal antibody treatments to COVID-19 patients early this year, spending loads of cash on therapies that had been deemed of no benefit, a new study has found. The U.S. Food and […]


Pricing, Regulations

Pharma prepares to continue fight as drug pricing bill passes House

August 15, 2022

Via: Biopharma Dive

The pharmaceutical industry is gearing up to minimize the effect of major drug legislation passed by Congress on Friday, the first time in many years lawmakers have overcome the drug lobby’s opposition to limits on their pricing power. On Friday, […]


FDA, Regulations

Repeat At-Home COVID Tests Needed to Confirm Negative Result, FDA Says

August 12, 2022

Via: Drugs.com

People who test at home after being exposed to COVID-19 should take the test three, not two, times to make sure they’re not infected, the U.S. Food and Drug Administration said Thursday. In issuing its new safety communication, the agency […]


FDA, Regulations

Common Diabetes Drug Januvia May Contain Traces of Carcinogen, FDA Says

August 12, 2022

Via: Drugs.com

The popular diabetes drug Januvia may contain traces of a probable carcinogen, but patients should keep using the medication because it could be dangerous to stop taking it, the U.S. Food and Drug Administration announced this week. Despite the discovery […]


FDA, Regulations

Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

August 9, 2022

Via: PMLiVE

The decision was based on the ARASENS trial, which demonstrated that adding Nubeqa to standard androgen deprivation therapy (ADT) and docetaxel chemotherapy led to a statistically significant improvement in overall survival compared to ADT plus docetaxel and placebo. The results, […]