Newsfeeds - Spark Newswire

4 minute read

Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

Today, 7:11 AM

The month of April was a mixed one for regulatory approvals. The Food and Drug Administration delayed approvals for at least three treatment candidates. New molecular entity, or NME, approvals, a measure of innovation in drug research, tapered to merely one for the month.

BMY

4 minute read

The Daily Biotech Pulse: Moderna Seeks FDA Approval For COVID-19 Shot For Children 2-6, Tax Disclosure For Amgen, Fast Track Tags For SQZ Biotech, Timber Pharma Candidates

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours:

ABBV

4 minute read

The Daily Biotech Pulse: Molecular Partners Plunges On Double Bad News, Pfizer/BioNTech Seek Nod For COVID-19 Shot In Kids, Pfizer Invests In Zentalis

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours.

ACHV

4 minute read

The Daily Biotech Pulse: Protagonist’s Ulcerative Colitis Study Disappoints, Gilead’s Remdesivir Approved For Pediatric COVID-19 Patients, FDA Gives Nod To Gamida’s Cell Therapy Trial, Fast Track Tag For Vascular Biogenics Ovarian Cancer Gene Therapy

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours:

AGRX

4 minute read

The Week Ahead In Biotech (April 24-April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Decisions, Big Pharma Earnings, IPOs And More

By Shanthi Rexaline

Today, 7:11 AM

Biotech stocks extended their loses in the week ending April 22. The sector took cues from the broader market, which reacted to the lackluster start of the first-quarter reporting season and lingering rate hike fears.

ABBV

3 minute read

The Daily Biotech Pulse: WHO Endorses Pfizer’s Oral COVID Therapy, Vallon Pharma Surges On Strategic Review, Novavax Starts Dosing In Adolescents COVID Booster Trial

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours.

GILD

2 minute read

The Daily Biotech Pulse: Windtree Jumps On Istaroxime Data, Arcturus’ COVID-19 Vaccine Trial Data, FDA Rejects Teva’s Schizophrenia Med, Otonomy Aces Hearing Loss Study

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours.

ALVR

2 minute read

The Week Ahead In Biotech (April 17-April 23): J&J, Abbott Earnings, Adcom Test For TG Therapeutics And More

By Shanthi Rexaline

Today, 7:11 AM

Biotech stocks retreated in the week ending April 14, lock-stepping with the broader market. The news flow was light during the holiday-shortened week and ahead of the imminent first-quarter reporting season.

ABT

4 minute read

The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Booster Data In Kids, Regeneron’s COVID-19 Therapy Decision Pushed, Protagonist’s Rusfertide Breakthrough Tag Update And More

By Vandana Singh

Today, 7:11 AM

Here's a roundup of top developments in the biotech space over the last 24 hours:

ABBV

2 minute read

The Week Ahead In Biotech (April 3-April 9): BioXcel FDA Decision, Neurology Conference Presentations Take The Spotlight

By Shanthi Rexaline

Today, 7:11 AM

Biopharma stocks outperformed the broader market in the week ending April 2, thereby recouping the losses from the previous week. Clinical readouts and FDA decisions were among the chief catalysts that moved stocks during the week.

ACAD