Fierce Pharma

FEBRUARY 15, 2024

Takeda won FDA approval for Eohilia after a rejection in 2021. Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics.

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MedCity News

JUNE 28, 2023

Ngenla, a hormone drug from partners Pfizer and Opko Health, is now FDA approved for treating children with growth hormone deficiency. The once-weekly injectable biologic will compete against an Ascendis Pharma product that won its FDA approval in 2021.

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Fierce Pharma

SEPTEMBER 22, 2023

Fast on the heels of winning a European approval to treat chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim's versatile SGLT2 inhibitor Jardiance is expanding its reach in the U.S., | After AstraZeneca's Farxiga won a class-first chronic kidney disease approval back in 2021, Eli Lilly and Boehringer are entering the fray with (..)

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MedCity News

MAY 25, 2023

Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.

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European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,

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Tribeca Knowledge

NOVEMBER 16, 2021

The trend for 2021 new drug approvals in both the US and the European Union, the two most important launching pads for innovative medicines worldwide, has more than kept pace with 2020.

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Pharmaceutical Technology

FEBRUARY 8, 2024

This initiative builds on the original parallel scientific advice programme launched by the FDA and EMA in 2021.

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pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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Pharmaceutical Commerce

JANUARY 9, 2024

Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

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Pharmaceutical Technology

DECEMBER 15, 2023

This is the second FDA approval for MSD’s HIF-2α inhibitor following a 2021 approval to treat von Hippel-Lindau disease.

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Pharmaceutical Technology

NOVEMBER 29, 2023

BrainStorm Cell Therapeutics’s NurOwn is approaching the conclusion of a three-year regulatory journey that commenced in February 2021 when the US Food and Drug Administration (FDA) advised against filing a Biologics License Application (BLA).

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MedCity News

MAY 31, 2024

The antibody drug conjugate had received accelerated FDA approval for this type of cancer in 2021. Gilead Sciences reported Trodelvy’s Phase 3 test in metastatic urothelial cancer fell short of showing a statistically significant benefit on the overall survival main goal.

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Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

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European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. The regulator had previously granted breakthrough therapy and orphan drug designations to Vowst.

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Pharmaceutical Technology

JUNE 12, 2023

The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list.

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care?

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pharmaphorum

JANUARY 4, 2023

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

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World of DTC Marketing

FEBRUARY 1, 2022

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. According to EY, there were 69 deals worth $128 billion in 2020 and 90 deals worth $108 billion in 2021.

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pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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Pharma Marketing Network

SEPTEMBER 15, 2021

In recent years the European Union has updated their requirements for Medical Device reporting following the FDA in the United States mainly with the EU Medical Device Regulation. Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. REGISTER TODAY.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication of AbbVie ’s Qulipta (atogepant) as a preventive treatment for chronic migraines in adult patients. Qulipta received the FDA’s approval to treat episodic migraine in adults in September 2021.

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Pharma Marketing Network

JULY 7, 2021

Pfizer’s size, solid manufacturing capability and experience running large scale vaccine trials combined with BioNTech’s strong science created a synergistic effect that resulted in the first COVID-19 vaccine approved by the FDA for emergency use in December 2020, just 336 days after the genetic blueprint of the virus was published.

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Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord US received exclusive rights for developing and marketing HLX02 in Canada and the US in 2021. More importantly, we prioritise the needs of patients.”

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Pharmacy Times

MAY 22, 2023

Avapritinib has been FDA approved for the treatment of advanced systemic mastocytosis since June 2021.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The company’s NDA was supported mainly by the data obtained from the Phase I clinical trial completed in June 2021, and the Phase III ASCEND trial.

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Pharmaceutical Technology

MARCH 30, 2023

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition.

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Pharmaceutical Commerce

FEBRUARY 16, 2024

Tepmetko (tepotinib), an oral MET inhibitor, was granted accelerated approval in 2021 for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

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European Pharmaceutical Review

NOVEMBER 22, 2022

The US Food and Drug Administration ( FDA ) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

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Clarivate

AUGUST 2, 2022

The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. The only exception was the TGA, which had a median approval time of 350 days in 2021, compared to 315 days in 2020.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir).

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PharmExec

APRIL 10, 2024

Decree comes amid the FDA’s 2021 inspection of Philips’ Murrysville facility and the subsequent voluntary recall of its sleep and respiratory care devices.

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Pharmaceutical Technology

MARCH 14, 2024

The new drug application included data from the Phase III eXalt3 study, published in JAMA Oncology in September 2021.

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MedCity News

OCTOBER 18, 2022

Eli Lilly is acquiring Akouos on the heels of the biotech receiving FDA permission to begin a clinical trial testing its gene therapy for an inherited form of hearing loss. The deal is Lilly’s second gene therapy acquisition following the 2021 buyout of Prevail Therapeutics.

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PharmExec

JANUARY 31, 2024

Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency's Peripheral and Central Nervous System Drugs Advisory Committee.

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